Zealand Pharma (ZEAL) Study Result summary

Study background and rationale

• Petrelintide is a long-acting amylin analog developed as a monotherapy for weight management, aiming to provide an alternative to GLP-1-based therapies with a differentiated mechanism of action and improved GI tolerability.

• Obesity rates are rising globally, with current treatment rates at only 2%-3% of the addressable population, highlighting the need for novel therapies.

• GLP-1-based therapies show 15%-21% mean weight loss but have high discontinuation rates due to GI side effects, creating demand for alternatives.

• Petrelintide's mechanism increases satiety and restores leptin sensitivity, with potential cardiovascular benefits.

Phase 1b trial design and population

• The Phase 1b trial was a randomized, double-blind, placebo-controlled study with 48 adults (median age 49, median BMI 29–29.2 kg/m²), randomized across three dose cohorts and placebo for 16 weeks.

• No specific diet or activity intervention was provided; 79%–80% of participants were male.

• Baseline characteristics were balanced; all participants had HbA1c <6.5%.

Efficacy results

• Mean body weight reductions at 16 weeks were up to 8.6% for the highest dose cohort, versus 1.7% for placebo.

• All participants on petrelintide lost weight, with higher doses showing greater separation from placebo.

• Indirect cross-trial comparisons suggest petrelintide's weight loss is comparable to GLP-1RA therapies at 16 weeks.

• Weight loss continued throughout the treatment period, with no early plateau observed.