Overview
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.
Eligibility
Inclusion Criteria:
- Signed informed consent
- Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2
- Screening HbA1c <6.5 %
Exclusion Criteria:
- Previous documented diagnosis of diabetes mellitus
- Self-reported change in body weight >5% within 3 months before Screening
- Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
- Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)
