A Study to Evaluate ALN-2232 in Participants With Obesity

Phase 2RecruitingNCT07463846

Alnylam Pharmaceuticals156 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

156

Conditions

Obesity

Interventions

ALN-2232DRUG

ALN-2232 will be administered subcutaneously (SC)

PlaceboDRUG

Placebo will be administered SC

TirzepatideDRUG

Tirzepatide will be administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Site

Montreal, Canada

RECRUITING

Outcomes

Primary Outcomes

Part A: Frequency of Adverse Events (AEs)

Time frame: Up to 12 months

Part B: Percent Change from Baseline in Body Weight

Time frame: Baseline up to Month 6

Part C: Percent Change from Baseline in Body Weight

Time frame: Baseline up to Month 6

Secondary Outcomes

Part A: Change from Baseline in Proteins in Adipose Tissue

Time frame: Baseline up to Month 12

Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma

Time frame: Predose and up to 15 days postdose

Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma

Time frame: Predose and up to 15 days postdose

Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma

Time frame: Predose and up to 15 days postdose

Part A: Fraction of ALN-2232 excreted in urine

Time frame: Predose and up to 8 days postdose (fe)

Part A: Percent Change from Baseline in Body Weight

Time frame: Baseline up to Month 12

Part B and Part C: Concentrations of ALN-2232 in Plasma

Time frame: Predose and up to 6 months postdose

Part B and Part C: Percent Change from Baseline in Body Weight

Central Contacts

Alnylam Clinical Trial Information Line

CONTACT

1-877-ALNYLAM clinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

CONTACT

1-877-256-9526 clinicaltrials@alnylam.com

Data from ClinicalTrials.gov

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