Novo Nordisk's Ozempic met its primary endpoint in a Phase 3b study of 302 Type 2 diabetes patients already on treatment with an SGLT-2 inhibitor, beating out placebo in lowering blood sugar, according to newly released data published in The Lancet.
The injectable GLP-1 receptor agonist also achieved the study's secondary goal, helping patients in the treatment arm lose more weight over 30 weeks than those on placebo.
The study is the company's ninth in a global, 10-trial program that enrolled more than 8,700 long-time Type 2 diabetes patients. Continued clinical success is crucial for Novo, which faces a competitive diabetes market and a GLP-1 rival in Eli Lilly's Trulicity.
Though Novo's market share for Ozempic (semaglutide) has grown, Eli Lilly's Trulicity (dulaglutide) remains a strong competitor. At the end of January, Ozempic held a 24% share of weekly new-to-brand prescriptions in the GLP-1 market, below Trulicity's 36%, according to Iqvia sales estimates cited by Credit Suisse.
Credit Suisse analyst Vamil Divan wrote in a February note that Novo's fiscal 2018 results "highlighted continued progress for their GLP franchise," which saw a 19% bump in sales driven by Ozempic.
Aiming to further build Ozempic's presence, Novo last year launched a DTC ad campaign for the drug.
Amid this competitive market, the results Novo released Monday from SUSTAIN 9 could help.
The trial was meant to assess the safety and efficacy of Ozempic, a once-weekly injection, in combination with SGLT-2 inhibitors.
Results showed treatment with Ozempic led to a 1.5% decrease in A1C levels, compared to 0.1% with placebo, a statistically significant difference. Patients randomized to receive Ozempic also lost just under 11 pounds on average, compared to those who received placebo, who lost about 2 pounds.
"Despite current treatment, almost 50% of people with Type 2 diabetes are still living with uncontrolled blood sugar," said Mads Krogsgaard Thomsen, science officer of Novo Nordisk, in a company statement.
Ozempic was approved by the FDA in December 2017. Novo is also developing semaglutide in an oral formulation, which would be the first pill in the GLP-1 class. The company is expected to seek FDA approval for that version sometime this year.