Phase 1 Study to Assess Safety, Tolerability, and Body Effects of LAE103 Alone and With LAE102 in Healthy Overweight or Obese Adults and Postmenopausal Women

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes the drug LAE103 in healthy overweight or obese adults and healthy postmenopausal women. This Phase 1, randomized, double-blind study also explores the safety and early effects of multiple doses of LAE103 and examines the safety and pharmacokinetics of LAE103 when combined with another drug, LAE102, in overweight or obese participants. The study aims to gather important information about these treatments in these specific groups to support further research. The study includes several parts a single-dose escalation in overweightobese participants, a single-dose in postmenopausal women, a multiple-dose escalation in overweightobese participants, and a single-dose co-administration of LAE102 with LAE103 in overweightobese participants. About 104 participants will be enrolled across 13 groups, each with 8 people randomized to receive either the study drug or placebo. Treatments are given as subcutaneous injections, with some participants receiving LAE103 alone, some saline as placebo, and others the combination of LAE102 and LAE103. Participants will attend study visits for monitoring during the treatment and follow-up periods, which last up to 70 days for single-dose parts and up to 98 days for multiple-dose parts. Researchers will assess safety by tracking any treatment-related side effects and monitor how the drug moves through and affects the body using blood tests for drug levels and biological markers. They will also test for immune responses to the drug and evaluate hormone levels. This thorough monitoring helps ensure participant safety and gathers comprehensive data about the treatments.

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants