Zealand Pharma Shares Fall 12% After Trial Side Effects
Zealand Pharma Ltd reported that its shares dropped as much as 12.5% on Thursday following the release of data from a late‑stage, 76‑week Phase III trial (SYNCHRONIZE‑2) of its obesity drug survodutide. The trial involved 755 overweight or obese adults with type 2 diabetes who received weekly injections of either 3.6 mg or 6 mg survodutide or a placebo.
Patients treated with survodutide achieved an average body‑weight reduction of 13.1%, compared with 3.1% in the placebo arm, and 79.3% of survodutide recipients lost at least 5% of their weight versus 32.7% of placebo patients. The drug also lowered average HbA1c levels by up to 1.21 percentage points from a baseline of 7.4%, whereas the placebo group saw a 0.03‑point reduction.
However, 18% of participants on survodutide discontinued treatment because of gastrointestinal adverse events—nausea, vomiting, diarrhea and constipation—most of which were mild to moderate, compared with only 1.2% discontinuations in the placebo group. The majority of these discontinuations occurred during the dose‑escalation period.
The trial met its primary objectives of weight loss and the proportion of patients achieving ≥5% weight reduction, with statistical significance reported as nominal. Survodutide is a dual‑action molecule targeting glucagon and GLP‑1 receptors and is licensed by Zealand to Boehringer Ingelheim, which is responsible for global development and commercialisation. The drug has not yet received regulatory approval, and its safety and efficacy remain to be fully established. Boehringer Ingelheim is concurrently conducting a separate Phase III trial (SYNCHRONIZE‑T2D) to evaluate survodutide’s impact on blood‑sugar control in type 2 diabetes patients. Zealand also indicated that results from an independent cardiovascular outcomes trial are expected later in the year.
A smaller body‑composition substudy (SYNCHRONIZE‑1) involving 75 individuals without diabetes showed that muscle accounted for no more than 10% of total tissue loss.