Zealand Prepares Novo Competitor for Key Weight Loss Therapy Following Phase 1 Data

Zealand Pharma is positioning itself to compete with Novo Nordisk by advancing its promising obesity treatment, petrelintide. The Danish biotech recently reported Phase 1b trial results that suggest petrelintide could offer similar efficacy to GLP-1 drugs without the associated side effects.

Petrelintide is a long-acting amylin analog, a new approach to weight management that Zealand believes could outperform existing treatments. Novo Nordisk, known for its GLP-1 drugs Ozempic and Wegovy, is also developing an amylin analog called cagrilintide. However, Zealand is confident that petrelintide could be the best-in-class option and presented data from its Phase 1b study to support this claim.

The Phase 1b trial involved 48 adults with overweight or obesity who were randomized to receive one of three doses of petrelintide or a placebo over 16 weeks. The participants had a median baseline BMI of 29, which is relatively low for weight-loss studies, and most were male—who typically lose less weight on GLP-1 drugs. Due to dose titration, those on the higher doses of petrelintide spent six to eight weeks on the maintenance dose.

Results after 16 weeks showed promising outcomes: participants on the two higher doses of petrelintide experienced mean body mass reductions of 8.6% and 8.3%, respectively, compared to a 1.7% reduction in the placebo group. The continued weight loss observed towards the end of the trial has strengthened Zealand’s belief that petrelintide could achieve weight reduction in the 15% to 20% range, similar to GLP-1 drugs.

David Kendall, M.D., Chief Medical Officer at Zealand, noted no signs of an early plateau in the treatment response. He anticipates ongoing weight loss over an extended period, potentially exceeding one year, aligning with regulatory requirements that now allow for more extended observation periods beyond 76 weeks of therapy.

One of the key advantages of petrelintide lies in its gastrointestinal tolerability. GLP-1 drugs often cause nausea and other gastrointestinal issues, which some patients find intolerable. Zealand is positioning petrelintide as a viable alternative for those who cannot handle GLP-1 drugs or seek a more tolerable weight management option. In the Phase 1b trial, two instances of moderate gastrointestinal adverse events—nausea and vomiting—were reported, affecting one participant who subsequently discontinued the treatment. Other gastrointestinal issues were mild, with no other participants discontinuing due to adverse events. Nausea was reported by up to 33.3% of those on petrelintide, compared to 16.7% in the placebo group, but these cases were mostly transient and decreased significantly over time.

Following the positive data, Zealand’s stock surged by 20%, reaching 775 Danish kroner in early trading in Copenhagen. The company is now planning a Phase 2b trial in the latter half of the year, involving over 400 adults with overweight or obesity. This trial will assess various doses of petrelintide over 42 weeks, with percentage change in weight as the primary endpoint. Zealand will also explore muscle preservation, an area where it believes petrelintide may have an advantage over GLP-1 drugs.

CEO Adam Steensberg, M.D., emphasized that while Zealand has the capability to advance petrelintide into Phase 2b, the ultimate objective is to “find a very committed partner” to support the extensive financial and logistical requirements of establishing petrelintide as a key weight-loss therapy. Zealand is already in advanced discussions with potential partners who share their vision for the product. These partnerships will be crucial for global outreach and investment in manufacturing.

Novo Nordisk’s strategy of combining its amylin analog with the active ingredients in Ozempic and Wegovy to create CagriSema highlights the potential for combination therapies, an avenue that Zealand may also explore with petrelintide.