Zealand Pharma reports up to 9.2% weight loss in Phase 2 diabetes trial
The 220-person ZUPREME-2 trial also showed improved HbA1c; Zealand says the first participants have begun treatment in its Phase 3a program.
Adrian Kessler
Weight loss of up to 9.2 per cent in a diabetes trial adds evidence for petrelintide's obesity program after Zealand Pharma A/S CPHZEAL said Wednesday its Phase 2 ZUPREME-2 study met the primary endpoint against placebo. Placebo recipients lost 2.0 per cent at week 28 under the company's efficacy analysis.
The 220-person U.S. study assigned adults with overweight or obesity and type 2 diabetes to three weekly petrelintide dose arms or placebo. HbA1c, a measure of blood sugar control, also improved in the treatment groups.
Zealand is a Danish biotechnology company developing peptide medicines for obesity and other metabolic conditions. Its petrelintide program has already moved into larger trials.
Nasdaq Copenhagen's delayed quote showed ZEAL at DKK 250.20 as of 10:56:54 a.m. CET on Wednesday. That reading predates Zealand's trial announcement and does not measure a market response to it. The company's investor calendar lists Nov. 12 for its third-quarter report.
All Three Doses Beat Placebo on Weight
Zealand said weight loss ranged from 7.4 to 9.2 per cent across the three petrelintide arms, against 2.0 per cent with placebo after 28 weeks. Those figures use the company's efficacy estimand; it said results were largely consistent under the treatment-regimen estimand.
The greatest reported HbA1c decline was 0.65 percentage points, while the placebo arm rose 0.23 points at week 28. Across the treated arms, the placebo-adjusted HbA1c reduction ranged from 0.61 to 0.88 percentage points. The participants took metformin, with or without an SGLT2 inhibitor, alongside diet and exercise measures.
Gastrointestinal adverse events led 1.9 per cent of petrelintide recipients and 1.7 per cent of placebo recipients to stop treatment. Zealand reported no unexpected safety signal and said most gastrointestinal events were mild and occurred while doses were being increased.
The topline announcement does not give p values, confidence intervals or dose-by-dose efficacy tables, though it calls all three weight-loss comparisons statistically significant. It also does not describe FDA feedback on the trial design, so the regulatory weight of this Phase 2 result remains unspecified.
"These results further support the potential of petrelintide in chronic weight management and, for the first time, demonstrate its promise as a standalone treatment for those living with overweight or obesity and type 2 diabetes," Zealand chief medical officer David Kendall said in the Oct. 7 release.
Zealand said its Phase 3a program comprises three studies expected to enrol about 7,000 participants, and the first patients have begun treatment. One of them, ZUPREME-4, is designed for people with overweight or obesity and type 2 diabetes, the population tested in ZUPREME-2. Zealand expects to present the full Phase 2 results at a scientific meeting but gave no date.
Its Aug. 13 half-year report listed DKK 14.457 billion in cash, cash equivalents and marketable securities as of June 30. Wednesday's trial release gave no cash-runway date.
Novo Has Later-Stage Amylin Diabetes Data
Novo Nordisk A/S CPHNOVO-B NYSENVO is developing CagriSema, a combination of the amylin agonist cagrilintide and semaglutide. Its Feb. 2 Phase 3 announcement reported results from 2,728 adults with type 2 diabetes.
At week 68, Novo reported 14.2 per cent weight loss with CagriSema against 1.5 per cent on placebo in its adherence-based analysis. Zealand tested petrelintide alone over a shorter period, so the separate trials cannot rank the drugs against each other.
Read more: Novo Nordisk reports normal liver fat in 23 of 26 Wegovy users
Viking Therapeutics, Inc. NASDAQVKTX closed at US$29.28 on Nasdaq as of 4 p.m. EDT on Oct. 5. Viking announced an oral obesity maintenance study on Oct. 6, so that close predates both announcements.
Read more: Viking Therapeutics begins oral VK2735 maintenance trial in obesity
Zealand's Nov. 12 third-quarter report is the next dated check on its cash position as the larger petrelintide studies proceed.
