Dapiglutide

Dapiglutide is being evaluated in a Phase 1b clinical trial.

In Part 1 of the Phase 1b dose titration trial a total of 54 participants (~85% male) with a median age of 46 years and a median BMI at baseline of 30 were randomized to receive 13 weekly doses of either dapiglutide or placebo within three dose cohorts. At week 13, the estimated mean body weight had decreased by up to 8.3% on a placebo-corrected basis among participants on dapiglutide treatment (up to 6.2% mean weight loss on dapiglutide; 2.1% mean weight gain on placebo). No lifestyle modifications, such as diet or exercise, were included in the trial. The most common treatment-emergent adverse events were GI-related, including nausea and vomiting. GI adverse events were consistent with the profile reported with other incretin-based therapies. Only two participants discontinued treatment due to GI adverse events (moderate vomiting). We presented these results at the Scientific Sessions of the American Diabetes Association in June 2025.

Part 2 of the Phase 1b trial includes an additional cohort to investigate higher doses over a treatment duration of 28 weeks. A total of 30 participants (~93% male) with a median age of 44.5 years, a median baseline body weight of 91.9 kg, and a median baseline BMI of 28.8 were randomized to receive 28 weekly doses of either dapiglutide or placebo (2:1) within one dose cohort. At week 28, the estimated mean body weight decreased by 11.6% from baseline among participants on dapiglutide treatment. Placebo treatment resulted in a mean body weight decrease of 0.2% from baseline. No lifestyle modifications, such as diet or exercise, were included in the trial.

Higher doses of dapiglutide compared Part 1 were assessed to be safe and well-tolerated in the trial, with no severe or serious treatment-emergent adverse events reported. The vast majority of treatment-emergent adverse events were mild and the most common were gastrointestinal, including nausea and vomiting. Two participants withdrew due to treatment-emergent adverse events reported, one of which was related to gastrointestinal events. Overall, the number of gastrointestinal events observed was consistent with clinical trials of other incretin-based therapies.

We expect to initiate a Phase 2b trial of dapiglutide.

Dapiglutide is an investigational compound whose safety and efficacy have not been evaluated or approved for marketing by any regulatory authority.