TLDR
- Zealand Pharma shares dropped as much as 12% on Thursday after late-stage trial data was released.
- The Phase III SYNCHRONIZE-2 trial tested survodutide in people with obesity and type 2 diabetes.
- Patients on the drug lost up to 13.1% of body weight versus 3.1% for placebo.
- 18% of patients on survodutide stopped treatment due to gastrointestinal side effects.
- Boehringer Ingelheim licenses survodutide from Zealand and runs its global development.
Zealand Pharma (ZEAL) stock fell as much as 12% on Thursday. The drop came after new trial results for its obesity drug survodutide were released to the public.
The results came from the Phase III SYNCHRONIZE-2 trial. It tested survodutide in adults with obesity or overweight who also have type 2 diabetes.
Patients taking survodutide lost up to 13.1% of their body weight on average. Those on a placebo lost just 3.1%.
The trial ran for 76 weeks. It included 755 adults who received weekly injections of either 3.6 mg or 6 mg of survodutide, or a placebo.
What Caused the Stock Drop
The weight loss numbers looked strong on paper. But investors focused on something else: how many people quit the treatment.
18% of patients taking survodutide stopped due to gastrointestinal side effects. Only 1.2% of the placebo group dropped out for the same reason.
The side effects included nausea, vomiting, diarrhea and constipation. Most cases were mild to moderate, according to Zealand.
Most of the dropouts happened during the dose escalation phase. That’s when patients were being moved up to higher doses of the drug.
Nearly 80% of patients on survodutide achieved at least 5% weight loss. In the placebo group, that figure was 32.7%.
The drug also lowered HbA1c, a marker of blood sugar control. Levels dropped by up to 1.21 percentage points from a baseline of 7.4%.
The placebo group only saw a 0.03 percentage-point reduction in HbA1c. The trial met both of its main goals.
The Drug’s Path Forward
Survodutide is a dual-action drug. It targets both glucagon and GLP-1 receptors.
Zealand Pharma licenses the drug to Boehringer Ingelheim. Boehringer handles its global development and commercial rollout.
The drug has not been approved anywhere yet. Its safety and effectiveness are still unproven in regulatory terms.
Boehringer is running a separate Phase III trial called SYNCHRONIZE-T2D. That study is looking at survodutide’s effect on blood sugar control specifically in type 2 diabetes patients.
Results from a cardiovascular outcomes trial, SYNCHRONIZE-CVOT, are expected later this year. That data could matter for how regulators and doctors view the drug’s long-term safety.
A smaller related study, SYNCHRONIZE-1, looked at body composition in 75 people without type 2 diabetes. It found muscle made up no more than 10% of total tissue lost during treatment.
The full SYNCHRONIZE-2 results were presented at the European Association for the Study of Diabetes annual meeting. They were also published in The New England Journal of Medicine on the same day.
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