Zealand Pharma (ZEAL) Shares Plunge 12% Despite Promising Obesity Trial Results

Key Takeaways

Table of Contents

Zealand Pharma experienced a share price decline of up to 12% following the publication of late-stage clinical trial results.
The SYNCHRONIZE-2 Phase III study evaluated survodutide in participants living with obesity and type 2 diabetes.
Trial participants receiving the treatment experienced body weight reductions of up to 13.1% compared to 3.1% in the control group.
Approximately 18% of survodutide recipients discontinued therapy due to digestive system adverse events.
Boehringer Ingelheim holds the license for survodutide from Zealand and oversees worldwide clinical development.

Shares of Zealand Pharma (ZEAL) experienced a decline of up to 12% during Thursday trading. The decline followed the public disclosure of new trial results for survodutide, the company’s investigational obesity treatment.

Zealand Pharma A/S, ZEAL

The data originated from the SYNCHRONIZE-2 Phase III clinical study. This trial evaluated survodutide in adult participants with obesity or excess weight who were also managing type 2 diabetes.

Study participants receiving survodutide achieved average body weight reductions of up to 13.1%. The control group receiving placebo experienced only 3.1% weight reduction.

The clinical study extended over 76 weeks. It enrolled 755 adult participants who were administered weekly injections at either the 3.6 mg or 6 mg survodutide dose level, or placebo.

Factors Behind the Share Price Decline

The weight reduction data appeared robust at first glance. However, market participants directed their attention toward a different metric: treatment discontinuation rates.

Approximately 18% of survodutide recipients withdrew from the study due to gastrointestinal adverse reactions. By comparison, just 1.2% of placebo recipients discontinued for similar reasons.

The adverse reactions encompassed nausea, vomiting, diarrhea and constipation. Zealand reported that the majority of these events were classified as mild to moderate in severity.

The bulk of study withdrawals occurred during the titration period. This phase involved gradually increasing patients to higher therapeutic doses.

Close to 80% of survodutide-treated participants reached at least 5% body weight reduction. Among placebo recipients, this proportion stood at 32.7%.

Survodutide also demonstrated improvements in HbA1c, a key indicator of glycemic management. This marker decreased by up to 1.21 percentage points from a starting value of 7.4%.

The control group experienced only a 0.03 percentage-point HbA1c reduction. The study successfully achieved both primary endpoints.

Development Trajectory for Survodutide

Survodutide operates through a dual mechanism of action. It activates both glucagon and GLP-1 receptor pathways.

Zealand Pharma has licensed this compound to Boehringer Ingelheim. Boehringer manages worldwide development activities and future commercialization efforts.

The compound has not yet received regulatory approval in any jurisdiction. Its safety profile and therapeutic efficacy remain under regulatory review.

Boehringer is conducting an additional Phase III investigation designated SYNCHRONIZE-T2D. This trial focuses specifically on survodutide’s impact on glycemic control in individuals with type 2 diabetes.

Findings from a cardiovascular outcomes study, SYNCHRONIZE-CVOT, are anticipated later this year. These results could influence how regulatory authorities and healthcare providers assess the drug’s long-term safety profile.

A smaller companion study, SYNCHRONIZE-1, examined body composition changes in 75 individuals without type 2 diabetes. It determined that muscle tissue comprised no more than 10% of the total tissue reduction during therapy.

Complete SYNCHRONIZE-2 findings were unveiled at the European Association for the Study of Diabetes annual meeting. The results were simultaneously published in The New England Journal of Medicine.

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