Wegovy, one of several drugs now surging in popularity due to their potent weight-loss effects, can also protect the heart, according to results from a large international study called SELECT.

The findings could catapult use of the drugs, known as GLP-1 agonists, even higher, and spur further changes in how doctors treat obesity. They're also a major boost to Wegovy maker Novo Nordisk, which holds pole position in a pharmaceutical industry race to make GLP-1 drugs the next multibillion dollar market.

Announced by Novo August 8, the study found treatment prevented heart attacks and strokes in overweight people with heart disease, reducing by 20% versus placebo their relative risk of cardiovascular complications and death.

Novo analyzed the results after 1,270 instances of heart attacks, strokes or cardiovascular death among study participants. Novo said “all three components” contributed to the reported risk reduction, suggesting a treatment benefit on each measure.

“People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death,” said Martin Holst Lange, Novo’s head of development, in the company’s statement. “SELECT is a landmark trial and has demonstrated that [Wegovy] has the potential to change how obesity is regarded and treated.”

Novo said it will ask regulators in the U.S. and Europe this year to expand Wegovy’s label to include the new data. It plans to share detailed study findings at a medical meeting in 2023.

Physicians already knew that weight loss brought on by Wegovy and drugs like it could improve markers of heart health like cholesterol and blood pressure. Previous testing had also found that Novo's diabetes drug Ozempic, which contains the same active ingredient as Wegovy, reduces heart risk.

But the new data Tuesday are the first time a weight-loss drug, when added to changes in diet and exercise, proved cardio-protective in a broad group of people. Unlike prior heart trials of Ozempic, which were limited to people with Type 2 diabetes, SELECT enrolled non-diabetic participants. It was particularly large, too, involving more than 17,000 adults across more than 40 countries.

Analysts view this kind of trial evidence as necessary to convince insurers to pay for Wegovy and other GLP-1 medicines like Ozempic that are being used for weight loss off-label. Many payers have been reluctant to widely cover them, while Medicare, the government insurance program for people 65 years or older, is prohibited by law from paying for weight-loss drugs.

“We definitely know these drugs work for weight loss,” Martha Gulati, director of preventive cardiology at Cedars-Sinai Medical Center, said in an interview. “In terms of accessing these medications, it’s quite the challenge. We do need to convince the insurers.”

Despite insurers’ resistance, GLP-1 drugs are in such demand that Novo can’t make Wegovy or Ozempic fast enough. Both are currently in shortage in the U.S.

Their popularity extends beyond doctors’ offices, with celebrities crediting Ozempic or Wegovy for their weight loss and TikTok videos racking up hundreds of millions of views. In some cases, people are willing to pay cash for the medicines, which cost between $900 and $1,400 for a typical month’s supply.

A recent survey of U.S. adults by the Kaiser Family Foundation found 70% had heard at least a little about “new weight-loss drugs.” Forty-five percent were either very or somewhat interested in taking them, although fewer remained interested if treatment wasn’t covered by their insurance.

In diabetes, GLP-1 drugs work by increasing the body’s production of insulin, thereby helping control blood sugar. They’re also thought to reduce appetite and increase a sense of post-meal fullness, furthering their effects on weight.

While they’re generally seen as safe, they do come with a range of possible side effects, including pancreatitis and kidney injury. Their surging use has also prompted regulators to probe other safety concerns, such as whether they’re associated with suicidal thoughts.

In SELECT, Wegovy “appeared to have a safe and well-tolerated profile” that was similar to previous testing, Novo said.

Industry experts estimate sales of GLP-1 drugs could reach as high as $50 billion by the end of the decade. Behind Novo stretches a line of competitors led by Eli Lilly and also including Pfizer and Amgen.

Lilly is seen as a particularly formidable competitor. Its drug Mounjaro, which targets GLP-1 and another hormone called GIP, is already approved in the U.S. for diabetes. In further testing, Mounjaro was found to help people lose up to one-fifth of their body weight — higher than what Wegvoy showed in Novo’s trials.

Lilly is expecting an FDA decision on approval of Mounjaro for weight loss by the end of the year. Already, the drug is being used for that purpose off-label, and is also in short supply.

While Mounjaro’s weight-loss benefit is competitive, the data Novo presented Tuesday could give Wegovy a potent advantage. Lilly does have a similar heart outcomes trial ongoing, but results aren’t expected until 2027.

These types of trials need to be particularly lengthy and large to detect a difference between drug and placebo on slow-emerging cardiovascular risk. SELECT is following participants for up to five years, for instance.

Because of this, their findings can be particularly persuasive. Similar types of cardiovascular studies were used to prove that an earlier class of diabetes drugs, called SGLT-2 inhibitors, were also beneficial in treating heart failure.

Novo and Lilly hope that their respective testing of GLP-1 drugs will bring a comparable rethink in how the treatments are used.

The results “should be meaningful for payers to drive improved coverage,” perhaps leading Medicare to start paying for Wegovy by the middle of 2025, wrote Jefferies analyst Peter Welford, in an Aug. 8 note to investors.

Ben Fidler contributed writing. 

Eli Lilly is at the forefront of two of the pharmaceutical industry’s hottest fields, and it’s paying off for the Indianapolis company’s investors.

Over the past year, Lilly’s valuation has climbed nearly 75% to touch $500 billion, putting the company above Johnson & Johnson as the world’s largest drugmaker by market capitalization. It’s worth nearly as much as Pfizer and Merck & C0. combined, despite earning less than one-third as much revenue as J&J or Pfizer in 2022.

Lilly’s skyrocketing stock price is largely due to two drugs: the diabetes and weight loss treatment Mounjaro, and the experimental Alzheimer’s treatment donanemab. Investors and Wall Street analysts expect both to become blockbusters in large markets with few established competitors.

In early May, results from a large clinical trial of donanemab in people with mild Alzheimer’s showed treatment slowed cognitive and physical decline by 35% versus a placebo, sending Lilly shares higher.

The positive data followed one week after Mounjaro succeeded in a second study testing its potential as a treatment for weight loss, setting Lilly up to seek an expanded approval for the Type 2 diabetes drug in obesity.

“We're seeing the practical benefits of life science innovation and years of investment,” former FDA commissioner and current Pfizer board member Scott Gottlieb wrote in a May 3 tweet. “Lilly stands at cusp of helping solve two of the most devastating chronic diseases: diabetes and obesity, and Alzheimer's.”

At least two investment banks upgraded their price targets on Lilly shares in May, setting expectations the company’s valuation will continue to rise.

“We think the efficacy and safety of [donamenab] could support a best-in-class amyloid plaque-targeting therapy for the treatment of Alzheimer's and broad reimbursement,” wrote Cantor Fitzgerald analyst Louise Chen, describing the drug’s mechanism of action.

Lilly’s rise to the top of the industry’s ranks is an achievement more than a decade in the making. In the early 2010s, the company endured one of the industry’s biggest patent cliffs as it lost patent protection for psychiatric drugs like Zyprexa and Cymbalta.

Yet Lilly never strayed from its research roots in neurological and metabolic medicine. Notably, it persisted in pursuing the much-debated “amyloid hypothesis” for treating Alzheimer’s, which posits that sticky plaques of that protein cause the disease’s progression.

The drugmaker exhausted nearly every possibility with the amyloid-targeting drug solanezumab, which failed six different Phase 3 trials, including those run by academic centers. By the time Lilly finally ended efforts with solanezumab, donanemab had emerged as the company’s top Alzheimer’s prospect.

The two drugs target different forms of the amyloid protein, a distinction that Lilly thought would result in greater amyloid clearance and better efficacy. That proved to be the case, as the company’s Phase 3 trial results showed donanemab slowed clinical decline as well as cleared amyloid plaques from the brains of most participants.

Lilly has restocked its Alzheimer’s pipeline beyond donanemab, too. Another amyloid-blocking drug called remternetug is beginning late-stage clinical testing, while a new kind of treatment that targets a different toxic protein called tau is in Phase 2 trials.

In metabolic care, Lilly has long leaned on its insulin products, and partnered with Boehringer Ingelheim to bring non-insulin diabetes medicines like Jardiance and Tradjenta to market. But it lagged rival Novo Nordisk in launching a drug that stimulates an insulin-regulating hormone called GLP-1.

Lilly eventually launched Trulicity, a once-weekly GLP-1 shot, in 2014. But the company didn’t test whether the drug could help people who are obese lose weight, as Novo did with its GLP-1 drug Saxenda.

It’s an opportunity Lilly didn’t pass up with Mounjaro, which stimulates GLP-1 and another insulin-raising hormone called GIP. Data released to date suggest Mounjaro may help people lose more weight than Novo’s drug Wegovy (marketed as Ozempic in diabetes), prompting SVB Securities analyst David Risinger, who also upgraded Lilly’s shares, to forecast annual sales of $28 billion by 2030.

Earlier in its pipeline, Lilly is testing an oral GLP-1, as well as a triple-acting drug in both diabetes and obesity.

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An experimental, triple-acting obesity drug from Eli Lilly helped some patients in a Phase 2 trial lose nearly a quarter of their body after 48 weeks, according to study results presented at a medical meeting in late June and published in the New England Journal of Medicine.

Patients treated with the highest dose of the drug, an injectable medicine called retatrutide, lost an average of 17.5% of their weight after 24 weeks, versus a 1.6% loss for placebo recipients. The effect size grew as time went on, with Lilly reporting a mean of 24.2% for those patients after 48 weeks.

As with other drugs like it, retatrutide was associated with gastrointestinal side effects such as nausea and vomiting. Wall Street analysts also flagged the potential for cardiovascular risk, as well as a type of skin sensitivity that occurred in 7% of treated patients compared to 1% of those who got a placebo.

Obesity drug development has quickly become one of the most competitive areas of biopharmaceutical research, with Lilly, Novo Nordisk and a group of would-be rivals racing for dominance of a market some analysts estimate to be worth more than $100 billion globally.

The annual meeting of the American Diabetes Association is the latest forum for the fast-moving competition, and one in which Lilly showcased its investments.

Already, Lilly has brought to market Mounjaro, an injectable medicine that’s approved for diabetes and could be cleared for use as an obesity treatment by the end of the year. Behind Mounjaro is an oral drug, orforglipron, that’s shown weight-loss effects in mid-stage testing that are comparable to injectable treatments.

Retatrutide is next in line and, unlike many obesity drugs in development, targets three hormones. Novo’s Wegovy acts on one, for instance, while Mounjaro homes in on two.

In the study presented at ADA, 338 patients received one of four different doses of retatrutide, or a placebo. At the start of the study, patients had a body-mass index of 30 or higher, or a BMI of 27 to less than 30 as well as a weight-related condition. The trial’s main goal was a change in body weight after 24 weeks. Secondary endpoints included a measure of weight after 48 weeks, as well as weight reductions of 5%, 10%, and 15% or more.

The drug’s effects on weight loss “triggered rare applause” from the crowd at the meeting and “may set a high bar for the next treatment wave” in obesity, wrote Jefferies analyst Peter Welford.

Welford also noted that all patients who received one of the top two doses lost at least 5% of their weight and nearly half of those on the highest dose lost more than 25%. “Remarkably the weight loss slopes continue to decline, suggesting greater effect in Phase 3 is possible,” he wrote.

The findings compare favorably to Mounjaro, which, in one of its Phase 3 trials, led to about a 20% weight loss after 48 weeks, wrote SVB Securities analyst David Risinger. But safety will be closely watched going forward. The study discontinuation rate was 16% for those on the highest dose. The appearance of a skin sensitivity side effect, cutaneous hyperesthesia, “drew attention,” Risinger noted. And “cardiovascular risk could be something to watch for,” he wrote, noting the instance in a single patient of a type of heart rhythm disruption called QT syndrome.

Lilly is investigating retatrutide in a large late-stage program involving at least four trials, among them studies in obesity and chronic weight management. Novo, meanwhile, has a newer medicine known as CariSegma that’s also in Phase 3 testing, and a pill that could be submitted to regulators this year.

Eli Lilly’s new medicine Mounjaro helped overweight people with diabetes lose about 30 pounds on average over an 18-month clinical trial, a significant result that boosts the drug’s chances of winning approval as a weight loss treatment.

The trial outcome, announced by Lilly April 27, confirm the findings of an earlier trial that included overweight people without diabetes. It is also likely to further raise the popular profile of drugs, such as Novo Nordisk’s Ozempic, that stimulate a hormone known as GLP-1 and have proved dramatically effective at helping people lose weight.

Mounjaro, which stimulates GLP-1 as well as another hormone known as GIP, gained Food and Drug Administration approval to treat diabetes in May 2022. Activating GLP-1 helps raise the body’s production of insulin to control blood sugar.

Lilly had already begun a “rolling” approval application to the FDA for Mounjaro’s use as a weight loss treatment, and later completed it with the data disclosed April 27. A decision from the agency is expected later this year. 

An approval would intensify Lilly’s rivalry with Novo Nordisk, which sells the daily shot Saxenda and a weekly injection called Wegovy for obesity. Ozempic, which contains the same active drug ingredient as Wegovy, is approved only for diabetes, but has been widely used off-label for weight loss.

A big market prize could await the companies, especially if one drug is viewed as more effective than another. Last year, Novo Nordisk reported combined obesity drug sales of about $2.4 billion. Lilly reported Mounjaro sales of nearly $570 million in the first quarter from its use treating diabetes.

The rapid uptake of the drugs has fueled sky-high sales forecasts for the broader class of GLP-1 drugs. Evaluate Pharma estimates as much as $50 billion in sales by 2028, while Pfizer CEO Albert Bourla recently said his company expects even higher market sales of up to $90 billion by 2030. (Pfizer is developing a GLP-1 drug, too.)

High demand has put pressure on supply. Both Lilly and Novo have run into difficulties making enough of their GLP-1 drugs over the past year. Wegovy supply was limited following manufacturing problems, while interest in Mounjaro following its diabetes launch outstripped Lilly’s production. 

Lilly appears confident Mounjaro has an advantage over Wegovy, recently beginning a late-stage study that will directly compare weight loss between people taking either drug. Data are expected in early 2025, according to a federal clinical trial database.

The trial Lilly disclosed results from Thursday, called SURMOUNT-2, enrolled more than 900 people with Type 2 diabetes and a body mass index of more than 27. Participants had to have stable blood sugar levels using diet and exercise or by any oral drug other than GLP-1s or another class called DPP-4 inhibitors.

The study was designed to measure weight loss among participants who received Mounjaro and compare to those given a placebo. Another goal assessed the share of people in both groups who lost at least 5% of their body weight.

Lilly won on both counts. Participants who took a 10 milligram dose of Mounjaro lost an average of 13.4% of their body weight, or about 30 pounds, while those on a 15 milligram dose shed 15.7% of their weight, or 34 pounds. Trial volunteers who were on placebo lost only 3.3% of their weight, or 7 pounds.

More than 80% of people on either Mounjaro dose lost at least 5% of their body weight, compared to only 30% of those on placebo.

The results are come close to matching findings from Lilly’s earlier SURMOUNT-1 study in obese and overweight people without diabetes, which showed an average of up to 21% body weight loss.

They also compare well to Wegovy, which resulted in average weight loss of up to 16% in testing. While the drugs are likely to be compared, the head-to-head trial Lilly is now enrolling will be a more definitive test of which is superior.

The most common adverse events reported in the trial were gastrointestinal in nature and generally mild or moderate in severity, Lilly said. Participants on the drug experienced nausea, diarrhea, vomiting and constipation more frequently than those on placebo.

Danish drugmaker Novo Nordisk on May 23 said a pill version of its popular obesity drug succeeded in a Phase 3 trial, delivering a comparable weight loss effect to what’s been observed in testing of its injectable counterparts.

In the study, overweight or obese patients lost an average of 15.1% of their body weight after taking the pill for 68 weeks, versus a 2.4% loss for placebo recipients. The results were similar to those for a weekly injectable version of the drug, semaglutide, that Novo sells as Wegovy.

Novo expects to file for approval in the U.S. and Europe in 2023. But it cautioned that the launch of the drug will depend on manufacturing capacity, which has been a struggle for Novo amid surging demand for Wegovy. A pill would be more convenient for patients.

The study results come two years after Novo won approval of Wegovy and five years after the clearance of Ozempic, a diabetes medicine also based on semaglutide and widely used off-label for weight loss.

The findings could spur even more interest in the medicines, which have become so coveted that Novo has had a hard time making enough doses.

Novo has repeatedly revised its production plans and sales outlook for Wegovy in the first year of its launch. But manufacturing issues have persisted, and last month Novo said it would add a second contract manufacturer to help. The Danish company has even paused an advertising campaign for Wegovy to slow the surging demand for the drug.

Amid Novo’s struggles, Eli Lilly is closing in with a rival medicine called Mounjaro. The drug, already approved for diabetes, has succeeded in two studies in obesity and could be approved as a weight loss treatment by the end of the year. Like Novo, Lilly is retooling its manufacturing to meet demand. Earlier this year, the company said it would add a new factory in North Carolina to increase supply of Mounjaro and Trulicity, another diabetes drug.

All of those medicines are injectable, however. Novo is leading an emerging race, involving Pfizer and biotech Viking Therapeutics, to develop pills that are just as effective. Data from an early study of one of Pfizer’s prospects were published in a medical journal in May.

The Phase 3 study Novo reported on, meanwhile, is one of four the company is running on oral semaglutide. Known as OASIS-1, it involved 667 adults who were either obese or overweight and had at least one comorbidity. Novo said around 89% of those who took the pill lost at least 5% of their weight, whereas about 25% of those on placebo hit that threshold.

The most common side effects reported were gastrointestinal, deemed mild to moderate in degree and diminished over time, the company said.

Eli Lilly has agreed to acquire privately held biotechnology company Versanis in a deal that will add an experimental antibody to Lilly’s pipeline of medicines for obesity.

The companies did not disclose a purchase price, but said in a statement July 14 that upfront and milestone payments by Lilly to Versanis shareholders could be worth as much as $1.9 billion.

Founded in 2021 by Aditum Bio, Versanis is built around a drug licensed from Novartis. The antibody, called bimagrumab, is designed to block cellular communication via two types of protein regulators and is being studied in people who are overweight or obese.

Lilly’s planned purchase of Versanis is the latest in a monthlong M&A streak that’s included acquisitions of Dice Therapeutics, Sigilon Therapeutics and Emergence Therapeutics.

The dealmaking gives Lilly new drug candidates in areas of research it has prioritized, like immune diseases, cancer and obesity. Its recent success developing drugs for the latter condition has fueled a stock price surge that’s made it the most valuable pharmaceutical company in the world.

Lilly’s most advanced drug in testing for weight loss, an injection called Mounjaro, targets a hormone called GLP-1, similar to Novo Nordisk’s wildly popular diabetes and obesity drugs Ozempic and Wegovy. Another promising medicine that’s not as far along also targets GLP-1, as well as two other hormones.

Versanis’ experimental obesity treatment works differently. It binds to proteins known as activin type II A and B receptors, which is thought to thereby block signaling via activin and myostatin. This kind of approach, the companies claim, could help reduce fat while preserving muscle mass.

Lilly envisions combining Versanis’ drug with its own GLP-1 medicines, which are known as incretins. “By unifying the knowledge and expertise in incretin biology at Lilly with the deep understanding of activin biology at Versanis, we aim to harness the potential benefits of such combinations for patients,” Ruth Gimeno, vice president of diabetes, obesity and cardiometabolic research, said in a statement from the company.

For Versanis’ investors Medixci and Atlas Venture, the deal is a quick return on investment. The two venture capital firms, together with Aditum Bio, raised $70 million in Series A financing for the biotech just under two years ago.

That money went toward launching a Phase 2 clinical trial of bimagrumab in about 500 adults who are overweight and obese. The study, which tested Versanis’ drug together with semaglutide, the active ingredient in Ozempic and Wegovy, is set to complete in September.

“This single-asset exit further strengthens our belief in delivering value via investing in focused, asset-driven companies,” said Nick Williams, a partner at Medicxi and a director on Versanis’ board, in a statement.

European Union regulators, worried that a new class of drugs including Novo Nordisk’s Ozempic may risk thoughts of self-harm or suicide, are broadening their review of the medicines.

The safety committee began its examination on July 3 after three reports from Iceland of people taking either the diabetes treatment Ozempic or another drug in the class, Saxenda, who had thoughts of suicide or self-injury. Originally, the review only focused on those two products and Wegovy, which contains the same active ingredient as Ozempic but is approved for weight loss.

Regulators now have about 150 reports of possible self-injury and suicidal thoughts, according to a statement released July 12. And they expanded the review to look at all of the drugs in the class, known as GLP-1 receptor agonists.

GLP-1 agonists have changed the treatment of diabetes and obesity, offering profound weight loss for patients and a multibillion-dollar opportunity for drugmakers led by Novo. The medicines brought in about 100 billion Danish kroner, or roughly $15 billion, in revenue for Novo last year.

But regulators want to make sure they understand all of the possible side effects, especially after the “fen-phen” controversy of the 1990s. In that case, half of a widely prescribed combination seen by some as a sort of magic treatment for weight loss was found to cause heart valve defects. The combination was later pulled off the market.

EU regulators said it’s not clear if the cases of self-harm and suicidal thoughts reported so far for patients on GLP-1 agonists are actually linked to the medicines or to other factors such as the patients’ underlying conditions. They expect to conclude their review in November.

Novo’s diabetes medicine Ozempic is the most well-known drug in the class, though it’s used off-label to treat obesity. Novo sells Wegovy and Saxenda for weight loss as well. Other GLP-1 agonists included in the EMA’s review are Eli Lilly’s Trulicity, AstraZeneca’s Bydureon and Sanofi’s Lyxumia.

Lilly also sells another diabetes drug, Mounjaro, that has shown promising results for weight loss. It targets GLP-1 as well as another receptor called GIP and wasn’t named in the EMA’s statement.

Pfizer is scrapping of one of two experimental weight-loss pills it’s been developing after spotting signs of potential safety concerns in clinical testing.  

The company on June 26 said the decision to stop testing of the pill, lotiglipron, was made after receiving the results from drug-drug interaction studies and observing liver enzyme elevations in early- and mid-stage tests. Patients with the liver enzyme spikes, which can be signs of organ damage, didn’t have side effects or require treatment, Pfizer said.  

Pfizer will now focus on its other, similar weight-loss prospect, danuglipron, which so far hasn’t had such concerns. Danuglipron is currently in Phase 2 testing in Type 2 diabetes and obesity, and could move into late-stage development by the end of the year.  

Like many of its peers, Pfizer is investing heavily in drugs for obesity, having brought two similar medicines known as GLP-1 agonists into mid-stage testing. 

Pfizer, though, is behind its rivals. Eli Lilly and Novo Nordisk have injectable drugs that are proven to help obese and overweight people lose weight. Lilly and Novo are also ahead with oral versions of their drugs, both of which are in late-stage testing. Results for each were presented at a medical meeting this weekend and show the potential for efficacy that’s comparable to what’s observed with injectable treatments. 

Still, Pfizer is putting significant resources into a plan to catch up. It’s been testing danuglipron and lotiglipron in parallel Phase 2 tests in diabetes and obesity, with science chief Mikael Dolsten telling Wall Street analysts earlier this year that the company planned to eventually “cherry pick” the best one.

Initially, Pfizer expected to make that call after observing Phase 2 study results. But the safety concerns that cropped up in testing of lotiglipron have accelerated Pfizer’s decision and placed more pressure on its other prospect to succeed. 

Danuglipron has shown promise. Study data in Type 2 diabetes, published in JAMA in May, showed treatment led to a similar level of weight loss as Novo’s medicines after 16 weeks. A Phase 2 study in obesity is fully enrolled, with data coming by the end of 2023, according to a federal database. Its safety profile so far has been “similar” to that of injectable GLP-1 drugs, and Pfizer hasn’t seen any evidence of liver enzyme elevations in the more than 1,400 patients who have been enrolled in its studies so far, Pfizer said.  

Yet results for lotiglipron had been eagerly anticipated because the drug is a once-daily pill. Danuglipron, by comparison, is taken twice daily. Though Pfizer said that it’s now developing a once-daily “modified release” version, the discontinuation of lotiglipron is a “big setback,” not just for its obesity drug ambitions but a “broader pipeline perspective, wrote Evercore ISI analyst Umer Raffat. 

”Sure, they’ll move forward with danuglipron … but it's not the best shot they had,” Raffat wrote.

The company expects to finalize its late-stage development plans by the end of the year. 

“We look forward to analyzing the danuglipron Phase 2 results and selecting the dose and titration schedule that will maximize the therapeutic benefit and safety and tolerability,” said William Sessa, the company’s senior vice president and chief scientific officer of internal medicine, in a statement. 

An experimental drug from Amgen helped people who are obese lose up to 15% of their body weight in a short study, a finding that has prompted executives to accelerate its development, the company said last November.

The data, revealed at a medical meeting, come from a small Phase 1 trial primarily designed to test safety and find the best dose of the drug to move into further testing.

The results suggest the treatment, known as AMG 133, could compete with treatments from Novo Nordisk and Eli Lilly because of its fast-acting effect and less frequent dosing.

Amgen enrolled 110 volunteers in the trial, testing low and high doses of the drug against a placebo. After 85 days, patients given three low doses of AMG 133 spaced four weeks apart lost 7% of their body weight, while those given three high doses lost 15%. By comparison, placebo recipients gained just over 1% in additional body weight.

Researchers haven’t observed any major safety issues and most side effects were “mild and transient,” Amgen said.

Based on those results, Amgen plans to “rapidly initiate” a Phase 2 program early next year that will recruit several hundred patients, including those with diabetes and other metabolic disorders, the company said.

Although AMG 133 hasn’t been tested extensively or for a long duration, the early findings suggest it could compare favorably to Novo’s Saxenda and Wegovy as well as Lilly’s diabetes drug Mounjaro, which is in late-stage testing as a weight-loss treatment.

Though comparing drugs across trials can be difficult, daily treatment with Saxenda resulted in average weight loss of around 5% to 7% after 56 weeks in Phase 3 testing, while weekly Wegovy treatment led to 10% to 16% reduction, on average, after 68 weeks. Patients who received Mounjaro in one of its two Phase 3 obesity trials lost 16% to 23% of their body weight in 72 weeks.

On an earnings call around the data’s release, Amgen executives were optimistic AMG 133 could stand out despite the competition.

“There are many potential avenues to differentiation here,” such as how fast AMG 133 can help patients lose weight, how long its effects last and its tolerability, said David Reese, Amgen’s head of research and development.

Novo had combined obesity drug sales of 8.4 billion Danish kroner, or about $1.3 billion, in 2021. Last year, the Danish company recorded sales of nearly $2.5 billion, a number that could have been higher except the company has had trouble producing sufficient supplies of Wegovy.

Mounjaro, meanwhile, is off to a fast start, earning $187 million in global revenue in its first full quarter on the market as a diabetes treatment. 

Wegovy, Mounjaro and AMG 133 all act on hormones that help control insulin production. Each does so differently, however. AMG 133 modulates a hormone called GLP-1, as well as another metabolic hormone called gastric inhibitory polypeptide, or GIP. 

An injection being developed by biotechnology company Viking Therapeutics for obesity helped adults enrolled in a small clinical trial lose up to 8% of their body weight, the company said in late March. If successful, the shot could compete with drugs from Novo Nordisk, Eli Lilly and others.

The Phase 1 trial was designed to find the best dose to advance into larger mid- and late-stage studies that Viking would use to prove the drug works. The largest weight loss reported was among trial volunteers who receive a dose as high as 10 milligrams per week. Participants given lower doses experienced less weight loss.

VK2735, as the injection is called, activates the same two insulin-stimulating hormones as Eli Lilly’s new diabetes drug Mounjaro, which is in the second of two Phase 3 trials before a planned application for approval as an obesity treatment. 

Novo Nordisk pioneered the use of insulin-stimulating diabetes drugs as weight loss treatments when it launched a high-dose version of its daily shot Victoza as Saxenda in 2014. It followed on that success years later with a weekly shot, marketed as Ozempic for diabetes and Wegovy for weight loss. (Ozempic is also being used off-label as a weight loss drug as demand has outstripped Novo’s supply.)

Those drugs activate only one insulin-secreting hormone, called GLP-1. Lilly’s Mounjaro stimulates a second one, dubbed GIP, and Viking — better known for development of an experimental drug for the liver disease NASH — is trying to duplicate that treatment approach.

Viking’s two-part study first enrolled adults to receive single doses of VK2735 to evaluate its safety and biologic activity, then enrolled people diagnosed as obese to take increasing weekly doses over four weeks. Ten participants also received a placebo.

Six people randomized to receive 0.5 milligrams of VK2735 during the four weeks of the trial lost 2.5% of their body weight, compared with 1.8% in the placebo arm, a difference that was not statistically significant. By comparison, the six patients given 5 milligram weekly dose and later 10 milligrams experienced a 7.8% lowering in body weight, which was considered a statistically significant difference versus placebo.

Side effects of the experimental drug included mild and moderate nausea, a common complaint of this class of drugs, but no one stopped treatment because of this side effect. One participant with a history of gallstones experienced a case of gall bladder obstruction, Viking said.

In testing its GLP-1/GIP drug, Viking avoided the fate of another company called Altimmune, which last week reported high dropout rates due to side effects in a trial of a similar weight loss drug.

In a statement, Viking said the side effect data suggests it could increase doses higher with a longer build-up period, an approach the company may try in a Phase 2 trial.

Viking also announced that it is planning to begin a Phase 1 trial of an oral version of VK2735.