Zealand Pharma and Roche to start petrelintide Phase 3 in H2 2026
Zealand Pharma has confirmed, alongside partner Roche, that petrelintide — a long-acting amylin analog for chronic weight management — will enter Phase 3 development in the second half of 2026. The decision follows positive topline data from the ZUPREME-1 Phase 2 trial, in which the once-weekly subcutaneous candidate delivered what the company described as double-digit percentage weight loss with a tolerability profile comparable to placebo.
The Phase 3 programme is designed to assess efficacy, safety, and tolerability in adults living with obesity or overweight accompanied by weight-related comorbidities. Zealand Pharma and Roche entered their co-development and co-commercialisation agreement for petrelintide in 2025.
The science and the deal
Petrelintide works via the amylin receptor rather than the glucagon-like peptide-1 (GLP-1) pathway that dominates the current approved landscape. Amylin is co-secreted with insulin from pancreatic beta cells in response to food intake; receptor activation is understood to promote satiety partly by restoring sensitivity to the hormone leptin. Zealand Pharma's engineering of the molecule specifically targeted chemical and physical stability, including resistance to fibrillation at neutral pH — a property intended to facilitate co-formulation with other peptides.
That co-formulation potential is central to the broader commercial logic of the Roche collaboration. A separate Phase 2 study evaluating petrelintide in combination with Roche's own GLP-1/GIP dual agonist enicepatide (CT-388) is planned to begin in the second quarter of 2026. If that combination data are positive, the partnership could position the two companies at the intersection of the amylin and incretin mechanistic classes — an area of active scientific and investor interest.
"By delivering exceptional tolerability and desired weight loss without disrupting daily life, we aim to redefine the weight management experience for people living with overweight and obesity," said Adam Steensberg, president and chief executive of Zealand Pharma.
Market context
The obesity therapeutics market has been reshaped rapidly by the commercial success of GLP-1 receptor agonists, notably semaglutide and tirzepatide. However, tolerability remains a meaningful clinical hurdle for a subset of patients: nausea, vomiting, and gastrointestinal side effects drive discontinuation rates that blunt real-world adherence. Amylin-based approaches are positioned by developers as a potentially better-tolerated alternative, or as a complement that allows lower doses of GLP-1 agents to be used in combination.
Zealand Pharma is not the only company pursuing this mechanistic angle. Independently, a number of academic and industry groups are exploring amylin receptor agonism, and Novo Nordisk has previously investigated pramlintide — an earlier amylin analogue — in combination contexts. The differentiation claim for petrelintide rests on its once-weekly dosing convenience relative to pramlintide's multiple-daily-injection profile, and on the fibrillation-resistant formulation that enables combination products.
For Roche, the collaboration represents a significant re-entry into metabolic disease after a period in which the Swiss pharma's pipeline was dominated by oncology and immunology assets. A successful Phase 3 outcome for petrelintide — or for the petrelintide-plus-enicepatide combination — would give Roche a credible position in one of the fastest-growing therapeutic categories in the industry.
Zealand Pharma was founded in 1998 and brings more than 25 years of peptide chemistry expertise to the partnership. The Copenhagen-headquartered company has two approved products on the market and three candidates in late-stage development. Investors will now focus on the Phase 3 protocol details — including the comparator arm, primary endpoint definition, and targeted patient population — expected to be disclosed closer to trial initiation.