Recruiting
Phase 1
Phase 2

ALN-2232

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT07463846

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ALN-2232

Placebo

Tirzepatide

Study Details

Brief 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

Conditions

Obesity

Study ID

NCT07463846

Start date

Mar 2, 2026

Status verified date

Aug, 2026

Completion date

Mar 2, 2028

Anticipated

Primary completion date

Apr 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: ALN-2232

Participants will be administered a single dose of ALN-2232

placebo comparator: Part A: Placebo

Participants will be administered a single dose of placebo

experimental: Part B: ALN-2232

Participants will be administered multiple doses of ALN-2232

placebo comparator: Part B: Placebo

Participants will be administered multiple doses of placebo

experimental: Part C: ALN-2232

Participants will be administered multiple doses of ALN-2232

placebo comparator: Part C: Placebo

Participants will be administered multiple doses of placebo

other: Part C: Tirzepatide

Participants will be administered multiple doses of tirzepatide once weekly

Interventions

ALN-2232

ALN-2232 will be administered subcutaneously (SC)

Placebo

Placebo will be administered SC

Tirzepatide

Tirzepatide will be administered SC

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Alnylam Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

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

Locations

Clinical Trial Site

Recruiting

Mount Royal, Canada, H3P 3P1

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • siRNA, RNAi therepeutic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-08-12.