Recruiting

ALN-2232 and Tirzepatide Safety, Tolerability, and Efficacy in Adults with Obesity

Study Aim

This study aims to evaluate the safety, tolerability, and effectiveness of ALN-2232 and Tirzepatide in adults with obesity, by observing the frequency of adverse events and measuring changes in body weight from the baseline.

What is being tested

ALN-2232

+ Tirzepatide

+ Placebo

Drug

Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

From 18 to 65 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2

Interventional

Study Start: March 2026

See protocol details

Summary

Principal SponsorAlnylam Pharmaceuticals

Study ContactAlnylam Clinical Trial Information LineMore contacts

Last updated: March 12, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 2, 2026

Actual date on which the first participant was enrolled.

This study focuses on a treatment for obesity. It aims to understand the safety, effectiveness, and how the body processes a new drug called ALN-2232, both on its own and when used together with another drug, Tirzepatide. The study involves adults living with obesity. The potential outcomes of this research could lead to improved treatment options and a better understanding of how these drugs work for individuals with obesity.

Official TitleA Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity

NCT07463846

Principal SponsorAlnylam Pharmaceuticals

Study ContactAlnylam Clinical Trial Information LineMore contacts

Last updated: March 12, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

156 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

Inclusion Criteria: All Parts: * Has a body mass index (BMI) of ≥30 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

7 intervention groups are designated in this study

42.857% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants will be administered a single dose of ALN-2232

Group II

Experimental

Participants will be administered multiple doses of ALN-2232

Group III

Experimental

Participants will be administered multiple doses of ALN-2232

Group IV

Placebo

Participants will be administered a single dose of placebo

Group 5

Placebo

Participants will be administered multiple doses of placebo

Group 6

Placebo

Participants will be administered multiple doses of placebo

Group 7

Participants will be administered multiple doses of tirzepatide once weekly

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Clinical Trial Site

Montreal, CanadaOpen Clinical Trial Site in Google Maps

Recruiting

One Study Center