A Study to Evaluate ALN-2232 in Participants With Obesity
Registered Phase 1/Phase 2 interventional trial (recruiting). The purpose of this study is to: * evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity
Registered clinical trial record on ClinicalTrials.gov (NCT07463846). This describes a planned, ongoing, or completed study โ it is NOT peer-reviewed results. Status: recruiting. Study type: interventional. Phase: Phase 1/Phase 2. Sponsor: Alnylam Pharmaceuticals. Conditions: Obesity. Interventions: ALN-2232, Placebo, Tirzepatide. Summary: The purpose of this study is to: * evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity Primary outcome measures: Part A: Frequency of Adverse Events (AEs); Part B: Percent Change from Baseline in Body Weight; Part C: Percent Change from Baseline in Body Weight. Eligibility: Inclusion Criteria: All Parts: * Has a body mass index (BMI) of โฅ30 kg/m\^2 and \<40 kg/m\^2 * Has a hemoglobin A1c (HbA1c) \<6.5% Exclusion Criteria: All Parts: * Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results * Receiving therapies for chronic weight management or antidiabetic medications Note: other protocol defined inclusion/exclusion criteria apply
This is a registered clinical-trial record from ClinicalTrials.gov โ a description of a planned, ongoing, or completed study, not peer-reviewed results. Listing on ClinicalTrials.gov does not mean the study has been evaluated by the U.S. Federal Government, nor does it imply endorsement or that the intervention is safe or effective.
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