A Study to Evaluate ALN-2232 in Participants With Obesity

Sponsor
Alnylam Pharmaceuticals
Study ID
NCT07463846
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ALN-2232 — DRUG
    ALN-2232 will be administered subcutaneously (SC)
  • Placebo — DRUG
    Placebo will be administered SC
  • Tirzepatide — DRUG
    Tirzepatide will be administered SC

Study Details

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

Key Dates

Start date
Mar 2, 2026
Status verified
May 2026
Primary completion
Apr 27, 2027
Completion
Mar 2, 2028

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Part A: Frequency of Adverse Events (AEs) [ Time Frame: Up to 12 months ]

Central Contacts

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