Clinical trial

Aleniglipron Phase 2 Body Composition Study

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07169942

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 79 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Overweight, or Chronic Weight Management

Full registry criteria

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)