Petrelintide delivers weight loss of up to 9.2%, paving the way for Phase 3 program
Key Facts
Zealand Pharma has advanced its drug petrelintide from Phase 2 results to a Phase 3 program after the ZUPREME-2 trial showed average weight loss of up to 9.2% after 28 weeks, compared with 2.0% with placebo. The company said in a statement via GlobeNewswire that results ranged from 7.4% to 9.2% across dose groups. The clinical data are central to the drug’s progress, while the next program will test the treatment in larger trials and across different patient groups. The company announced the results on October 7, ahead of the nine-month results news referenced in the story headline on November 12. The financial results detailed in the November 12 statement could not be reviewed from a reliable open source; therefore, this report does not include financial figures.
ZUPREME-2 included 220 people with overweight or obesity and type 2 diabetes. Average body mass index at the start of the trial was 36.3 kg/m², while average HbA1c, a measure of blood sugar levels, was 8.0%. At week 28, treatment recorded a reduction in HbA1c of up to 0.65%, compared with an increase of 0.23% with placebo. This result adds an indicator related to blood sugar control to the weight-loss data among participants with diabetes. The figures remain results from a Phase 2 trial, while the subsequent program will test the treatment on a broader scale.
Tolerability results showed that 1.9% of participants who received petrelintide discontinued because of gastrointestinal side effects, compared with 1.7% in the placebo group. Zealand Pharma said most gastrointestinal symptoms were mild and appeared during dose escalation. The measure puts side-effect-related discontinuation rates in the two groups side by side within the same trial. Tolerability remains part of the drug’s clinical assessment as it moves into broader testing. The next trials will provide additional data on its use in different patient groups.
Zealand Pharma is collaborating with Roche to develop petrelintide under an exclusive collaboration and licensing agreement that includes joint development and commercialization. The drug is also being developed on its own and in combination with enicepatide, known by the code CT-388. This means the development plan includes a path for the drug alone and another for the combination, alongside the collaboration between the two companies. Zealand Pharma had said a Phase 2 trial of the combination was planned to begin in the second half of 2026. This timeline links the results of the trial of the drug alone with the plan to test it in combination with CT-388.
The Phase 3 program comprises 3 trials targeting about 7,000 participants in total. Target groups include people with obesity or overweight without type 2 diabetes, others with the disease, and people with established cardiovascular disease. This design broadens the study compared with the ZUPREME-2 trial, which focused on people with overweight or obesity and type 2 diabetes. The upcoming trials are scheduled to test outcomes across these groups, after the Phase 2 trial showed weight, blood sugar and tolerability data over 28 weeks. In the November 10 session, ZLDPF shares closed at $36.75, according to EL7 data.