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Zealand Pharma Reports Positive Phase 2 Trial Results for Weight-Loss Drug Petrelintide

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Zealand Pharma A/S (OMXCOP:ZEAL) announced successful results from its Phase 2b clinical trial, ZUPREME-2, which evaluated its drug candidate petrelintide. The 28-week study involving 220 participants met its primary goal, showing that patients achieved a mean weight loss of up to 9.2%, compared to a 2.0% reduction for those on a placebo. Additionally, the drug demonstrated placebo-adjusted HbA1c reductions of 0.61% to 0.88%, indicating improved blood sugar control.

The results support the potential competitiveness of petrelintide in treating obesity and type 2 diabetes. The treatment also demonstrated a favorable safety profile with no unexpected adverse signals. Discontinuations due to gastrointestinal issues were low, affecting 1.9% of patients on the drug compared to 1.7% in the placebo group, which could support patient adherence.

Following these mid-stage findings, Zealand Pharma has initiated a Phase 3 trial program alongside Roche. Market observers will watch for longer-term data from these upcoming trials, specifically regarding cardiovascular and metabolic outcomes, which will be essential to evaluate the drug's full clinical value and commercial potential.

Key points

  • Zealand Pharma's Phase 2b trial of petrelintide met its primary endpoint, showing a mean weight loss of up to 9.2% compared to 2.0% for the placebo at 28 weeks.
  • The drug demonstrated placebo-adjusted HbA1c reductions ranging from 0.61% to 0.88%, indicating improved glycemic control.
  • Tolerability was high, with gastrointestinal side effect discontinuation rates at 1.9% for petrelintide versus 1.7% for the placebo.
  • Zealand Pharma has initiated a Phase 3 clinical trial program for petrelintide in partnership with Roche.

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Questions and answers

What were the results of the Zealand Pharma ZUPREME-2 trial?

The ZUPREME-2 Phase 2b trial of petrelintide met its primary endpoint, showing up to 9.2% mean weight loss compared to 2.0% for a placebo over 28 weeks. It also showed placebo-adjusted HbA1c reductions of 0.61% to 0.88% and had no unexpected safety signals.

Did petrelintide show any significant side effects in Phase 2?

No unexpected safety signals were reported in the trial. Discontinuations due to gastrointestinal adverse events were low, occurring in 1.9% of patients taking petrelintide compared to 1.7% of patients on the placebo.

What is the next step for Zealand Pharma's petrelintide?

Zealand Pharma has initiated a Phase 3 clinical program for petrelintide in partnership with Roche. Future milestones will include larger, longer-term trials evaluating the drug's efficacy, tolerability, and cardiovascular or metabolic outcomes.