A Study to Evaluate ALN-2232 in Participants With Obesity

Alnylam Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Obesity

Treatments: Drug: Tirzepatide; Drug: ALN-2232; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07463846

ALN-2232-001

Details and patient eligibility

About

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

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 7 patient groups, including a placebo group

Part A: ALN-2232

Experimental group

Description:

Participants will be administered a single dose of ALN-2232

Treatment:

Drug: ALN-2232

Part A: Placebo

Placebo Comparator group

Description:

Participants will be administered a single dose of placebo

Treatment:

Drug: Placebo

Part B: ALN-2232

Experimental group

Description:

Participants will be administered multiple doses of ALN-2232

Treatment:

Drug: ALN-2232

Part B: Placebo

Placebo Comparator group

Description:

Participants will be administered multiple doses of placebo

Treatment:

Drug: Placebo

Part C: ALN-2232

Experimental group

Description:

Participants will be administered multiple doses of ALN-2232

Treatment:

Drug: ALN-2232

Drug: Tirzepatide

Part C: Placebo

Placebo Comparator group

Description:

Participants will be administered multiple doses of placebo

Treatment:

Drug: Placebo

Part C: Tirzepatide

Other group

Description:

Participants will be administered multiple doses of tirzepatide once weekly

Treatment:

Drug: Tirzepatide