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Zealand Pharma's Petrelintide Shines In Phase 1b Trial, Paving The Way For Advanced Diabetes Therapy

Zealand Pharma's petrelintide shows promising weight loss results in Phase 1b trial for obesity treatment.

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  • Jun 21, 2024

  • Mrudula Kulkarni

Zealand Pharma's Petrelintide Shines In Phase 1b Trial, Paving The Way For Advanced Diabetes Therapy

Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology firm specializing in the creation and advancement of novel peptide-based medications, has reported encouraging top-line findings from the second segment of a Phase 1b trial examining multiple ascending doses (MAD). This trial evaluates the safety, tolerance, and therapeutic impacts of 16 weeks of petrelintide dosing, a long-acting analog of amylin being developed for weight management.

David Kendall, MD & Chief Medical Officer of Zealand Pharma, said in a statement, “The data reported from this 16-week trial are both exciting and compelling, demonstrating significant and clinically meaningful reductions in body weight with a very favorable tolerability profile. These results support our conviction that petrelintide is very well tolerated and can potentially play an important role as an alternative to incretin-based therapies for the management of overweight and obesity.

He further added, “These data pave the way for rapid progression to Phase 2b trials of petrelintide and further support the potential of this long-acting amylin analog to deliver weight loss comparable to GLP-1 receptor agonists with a better patient experience. We look forward to initiation of the Phase 2b clinical trial of petrelintide in people living with overweight and obesity later in 2024.”

In the second phase of the Phase 1b MAD trial, 48 participants (approximately 80% male) with a median age of 49 years and a median initial BMI of 29 kg/m² were randomly assigned to receive 16 weekly doses of either petrelintide or placebo (in a 3:1 ratio) across three dose groups. Among those who completed treatment with a high dose of petrelintide, the average body weight decreased by 8.6% from the starting point. In contrast, participants receiving placebo experienced an average decrease in body weight of 1.7% from the baseline.

Petrelintide was well tolerated during the trial, with no serious or severe adverse events reported. Most gastrointestinal side effects were mild, except for one participant who experienced moderate nausea and vomiting and discontinued treatment after the third dose. Importantly, no other participants stopped treatment due to side effects.

Vomiting was not reported by any other participants, and only two participants experienced mild diarrhoea. Nausea was reported by between 16.7% and 33.3% of participants in the active treatment groups, and by 16.7% in the placebo group. Injection site reactions were rare and mild, and no participants developed antibodies against the drug.

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