Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide
Company announcement – No. 15 / 2025
Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide
- Body weight reductions of a mean of 11.6% after 28 weeks with dapiglutide escalated up to 26 mg, with 95% of trial participants being male, a median baseline BMI of 28.5 kg/m2, and no lifestyle modifications
- Treatment with dapiglutide was assessed to be safe and well-tolerated with gastrointestinal adverse events consistent with the profile reported with other incretin-based therapies
- Unique, dual mechanism, including GLP-2 activity, designed to target obesity-related comorbid conditions driven by low-grade inflammation
Copenhagen, Denmark, June 18, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces positive topline clinical results from Part 2 of a Phase 1b multiple ascending dose (MAD) trial, investigating safety, tolerability, and clinical effects of 28 weeks of treatment with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist1.
“We are very encouraged by the impressive weight loss with dapiglutide after 28 weeks that appears on par with the most efficacious once-weekly GLP-1 receptor agonist-based therapy on the market today, despite the almost entirely male and relatively lean trial population,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. “Dapiglutide is a unique GLP-1 receptor agonist-based therapy, aiming to leverage a dual mechanism that includes GLP-2. Our mid- to late-stage obesity pipeline includes differentiated GLP-1 receptor agonist-based therapies that target people with obesity-related comorbid conditions, and our amylin analog, petrelintide, with potential as a foundational therapy for weight management, addressing unmet needs among the majority of people with overweight and obesity.”
In this Part 2 of the Phase 1b MAD trial, 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 kg/m2 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 baseline2. No lifestyle modifications, such as diet or exercise, were included in the trial.
Higher doses of dapiglutide compared to the prior 13-week Part 1 of the trial were assessed to be safe and well-tolerated in the trial, with no severe or serious treatment-emergent adverse events (TEAEs) reported. The vast majority of TEAEs were mild and the most common were gastrointestinal (GI), including nausea and vomiting. Two participants withdrew due to TEAEs, one of which was related to GI events. Overall, the number of GI events observed was consistent with clinical trials of other incretin-based therapies. A low number of participants reported injection site reactions, all of which were mild.
About the Phase 1b trial
The Phase 1b trial is a single-center, randomized, double-blind, placebo-controlled clinical trial in participants with overweight or obesity (eligible BMI 27.0 to 39.9 kg/m2), investigating safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of dapiglutide as subcutaneous injections using a dose escalation scheme (NCT06000891). No lifestyle modifications, such as diet or exercise, are included in the trial. The trial consists of Part 1 and Part 2.
Part 1 included 54 participants in three cohorts receiving 13 once-weekly doses of dapiglutide or placebo, with rapid dose escalation every second week. Participants randomized to the highest dose cohort (13 mg) received the target dose for a period of 5 weeks. Topline results from Part 1 showed placebo-adjusted reductions in body weight of up to a mean of 8.3% with dapiglutide after 13 weeks (up to 6.2% mean weight loss on dapiglutide; 2.1% mean weight gain on placebo)3. Detailed results from Part 1 of the Phase 1b MAD trial with dapiglutide will be presented at the American Diabetes Association’s 85th Scientific Sessions in Chicago, Illinois on June 20, 2025.
Part 2 of the trial includes 30 participants receiving 28 once-weekly doses of dapiglutide up to 26 mg or placebo within one dose cohort, with dose escalation every fourth week.
About dapiglutide
Dapiglutide is a long-acting, dual GLP-1/GLP-2 receptor agonist for the potential treatment of obesity-related comorbidities driven by low-grade inflammation. This is a potentially first-in-class peptide designed to leverage the weight loss effects of a potent GLP-1 receptor agonist and address comorbidities associated with low-grade inflammation through improved intestinal barrier function by GLP-2 receptor activation.
About low-grade inflammation and obesity
Excess fat storage associated with obesity can trigger low-grade systemic inflammation through reduced intestinal barrier integrity, or “leaky gut”. Obesity-related low-grade inflammation may result in several comorbidities, including cardiovascular disease, liver disease, inflammatory bowel disease, and neuroinflammation.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharmaceutical companies as well as commercial partnerships for its marketed products.
Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.
Forward looking statements
This company announcement contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political and geopolitical uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
Contacts
Adam Lange (Investors)
Vice President, Investor Relations
alange@zealandpharma.com
Neshat Ahmadi (Investors)
Investor Relations Manager
neahmadi@zealandpharma.com
Anna Krassowska (Investors and Media)
Vice President, Investor Relations & Corporate Communications
akrassowska@zealandpharma.com
Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
ZealandPharma@icrhealthcare.com
+44 (0) 7739 658 783
References
1. ClinicalTrials.gov. A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570. Available at https://clinicaltrials.gov/study/NCT06000891. Last accessed June 2025.
2. Hypothetical estimand = treatment effect if all participants adhered to treatment (also known as the efficacy estimand).
3. Zealand Pharma company announcement No. 44/2024, September 9, 2024. Available at https://www.globenewswire.com/news-release/2024/09/09/2943004/0/en/Zealand-Pharma-announces-positive-topline-results-from-13-week-Phase-1b-multiple-ascending-dose-clinical-trial-with-GLP-1-GLP-2-receptor-dual-agonist-dapiglutide.html.
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