Key takeaways:
- Dapiglutide was linked to weight reduction at 13 weeks at comparable ranges to different incretin-based therapies.
- The drug has anti-inflammatory results that will differentiate it from different weight problems remedies.
CHICAGO — Dapiglutide, a novel GLP-1/GLP-2 receptor agonist, was related to physique weight reductions of as much as 8.3% at 13 weeks for sufferers with obese or weight problems in an early research, researchers reported.
“Dapiglutide is a mixed GLP-1/GLP-2 agonist. The GLP-2 part has the potential for anti-inflammatory results, which is perhaps essential, as folks with weight problems usually have low-grade irritation [that] drives obesity-related comorbidities,” Tim Heise, MD, co-founder, lead scientist and chairman of the board of administrators at Profil, a contract analysis group primarily based in Neuss, Germany, who offered the findings on the American Diabetes Affiliation Scientific Periods, advised Healio.
For half one in all a part 1b a number of ascending dose research, whose major function was to find out security, the researchers randomly assigned 54 adults (imply age, 46 years; 85% males; imply physique weight at baseline, 95 kg) with BMI between 27 kg/m2 and 39.9 kg/m2 however no diabetes to obtain once-weekly subcutaneous dapiglutide (Zealand Pharma) 7.5 mg, dapiglutide 10 mg, dapiglutide 13 mg or placebo.
Every dapiglutide group was uptitrated step by step to their dose and took their treatment for 13 weeks. The follow-up interval for security outcomes lasted by way of 19 weeks.
Antagonistic occasions
Antagonistic occasions occurred in 66.7% of the placebo group, 100% of the dapiglutide 7 mg group, 100% of the dapiglutide 10 mg group and 92.9% of the dapiglutide 13 mg group, however most had been delicate, Heise stated throughout a presentation.
There have been two severe antagonistic occasions, each deemed not associated to dapiglutide. One affected person from the placebo group had diverticulitis and the feminine companion of 1 male affected person from the dapiglutide 10 mg group had a miscarriage.
The commonest antagonistic occasions had been gastrointestinal problems (41.7% of the placebo group, 71.4% of the dapiglutide 7.5 mg group, 85.7% of the dapiglutide 10 mg group and 85.7% of the dapiglutide 13 mg group) and respiratory, thoracic and mediastinal problems (33.3% of the placebo group, 57.1% of the dapiglutide 7.5 mg group, 28.6% of the dapiglutide 10 mg group and 35.7% of the dapiglutide 13 mg group), Heise stated in the course of the presentation.
He additionally stated in the course of the presentation that decreased urge for food occurred in 21.4% of the dapiglutide 7.5 mg group, 71.4% of the dapiglutide 10 mg group and seven.1% of the dapiglutide 13 mg group, “however in fact that might be an indication of efficacy.”
Injection-site reactions occurred in six sufferers from the dapiglutide teams and one affected person from the placebo group.
At 13 weeks, the estimated placebo-corrected imply % change in physique weight was –6.7% within the dapiglutide 7.5 mg group (95% CI, –9.6 to –3.8), –8.3% within the dapiglutide 10 mg group (95% CI, –11.1 to –5.5) and –7.1% within the dapiglutide 13 mg group (95% CI, –10 to –4.2), in response to the researchers.
‘Dapiglutide was nicely tolerated’
“This research was primarily a security trial, because it was an early part 1b a number of ascending dose trial,” Heise advised Healio. “Dapiglutide was nicely tolerated with uncomfortable side effects just like different incretin-based therapies. We did observe a considerable weight lack of as much as 8.3% (placebo-corrected), which is in the identical vary as the load loss noticed for different incretins over 16 weeks of therapy. One of many limitations of the trial was the low variety of females (girls are identified to have better weight reduction than males on common) and the speedy dose escalation each 2 weeks, so the total potential of dapiglutide’s weight-loss properties won’t have been noticed on this research.”
Half two of the research, which covers dose escalation as much as 26 mg at 28 weeks, will probably be offered at a future medical convention, Heise stated.
For extra data:
Tim Heise, MD, will be reached at tim.heise@profil.com.
Sources/Disclosures
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Maarbjerg SJ, et al. Summary 141-OR. Introduced at: American Diabetes Affiliation Scientific Periods; June 20-23, 2025; Chicago.
Disclosures:
The research was funded by Zealand Pharma. Heise studies his establishment obtained analysis grants from Adocia, Afon Expertise, AstraZeneca, Altimmune, Betagenon, Biocon, Bioton, Cass Prescription drugs, Civica Basis, Corteria, Cytoki, Eli Lilly, Enyo Pharma, Gan & Lee Prescription drugs, Genova, Nanexa, Neodyne, Novo Nordisk, SamChunDang, Spiden, Solar Pharma and Zealand Pharma. He additionally studies receiving speaker honoraria from Eli Lilly and Novo Nordisk and consulting for Gan & Lee Prescription drugs.
