Key Takeaways
- Zealand Pharma’s stock price plummeted by up to 12% Thursday following the release of late-stage clinical trial data.
- The SYNCHRONIZE-2 Phase III study evaluated survodutide in obese individuals living with type 2 diabetes.
- Participants receiving the treatment experienced weight reduction of up to 13.1% compared to 3.1% in the placebo arm.
- Nearly 18% of survodutide recipients discontinued therapy due to digestive system adverse events.
- Boehringer Ingelheim holds licensing rights to survodutide from Zealand and oversees worldwide clinical development.
Shares of Zealand Pharma (ZEAL) experienced a sharp decline of up to 12% Thursday. The selloff followed the public disclosure of fresh trial results for survodutide, the company’s investigational obesity treatment.
The data originated from the SYNCHRONIZE-2 Phase III clinical trial. This study evaluated survodutide in adult participants with obesity or excess weight who were also diagnosed with type 2 diabetes.
Individuals receiving survodutide achieved an average body weight reduction of up to 13.1%. By comparison, placebo recipients lost only 3.1% of their body weight.
The clinical trial spanned 76 weeks and enrolled 755 adult participants who were administered weekly subcutaneous injections at doses of either 3.6 mg or 6 mg of survodutide, or placebo.
Why Investors Reacted Negatively
While the weight reduction figures appeared impressive at first glance, market participants zeroed in on a different metric: the treatment discontinuation rate.
Approximately 18% of individuals receiving survodutide withdrew from the study due to gastrointestinal adverse effects. In stark contrast, only 1.2% of placebo recipients discontinued for similar reasons.
Common gastrointestinal complaints included nausea, vomiting, diarrhea, and constipation. Zealand indicated that the majority of these events were classified as mild to moderate in severity.
The bulk of treatment discontinuations occurred during dose escalation. This is the period when participants were gradually transitioned to higher dosing levels.
Close to 80% of survodutide-treated patients reached at least 5% body weight reduction. Among placebo recipients, this proportion stood at 32.7%.
Survodutide also produced improvements in HbA1c, a key indicator of glycemic control. Reductions reached up to 1.21 percentage points from a starting baseline of 7.4%.
The placebo cohort experienced only a minimal 0.03 percentage-point decrease in HbA1c. The trial successfully achieved both of its co-primary endpoints.
Next Steps for Development
Survodutide functions through a dual mechanism of action. It activates both glucagon and GLP-1 receptors simultaneously.
Zealand Pharma has licensed survodutide rights to Boehringer Ingelheim. Boehringer is responsible for global clinical development and future commercialization efforts.
The medication has not yet received regulatory approval in any jurisdiction. Its safety profile and efficacy remain under evaluation by health authorities.
Boehringer Ingelheim is conducting an additional Phase III study designated SYNCHRONIZE-T2D. This investigation focuses specifically on survodutide’s glycemic control benefits in type 2 diabetes patients.
Data from SYNCHRONIZE-CVOT, a cardiovascular outcomes study, is anticipated to be released later in 2025. This information may prove critical in shaping regulatory assessments and physician perceptions regarding the drug’s long-term safety profile.
A smaller companion study, SYNCHRONIZE-1, examined body composition changes in 75 individuals without type 2 diabetes. Findings indicated that muscle tissue accounted for no more than 10% of total weight lost during treatment.
Complete SYNCHRONIZE-2 findings were unveiled at the European Association for the Study of Diabetes annual scientific meeting. The results were simultaneously published in The New England Journal of Medicine.
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