A 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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
⁃ 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%
Locations
Other Locations
Canada
Clinical Trial Site
RECRUITING
Mount Royal
Contact Information
Primary
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2028-03-02
Participants
Target number of participants: 156
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals