A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:
⁃ Part A:
• Has a body mass index (BMI) of ≥27 kg/m\^2 and \<40 kg/m\^2
⁃ Part B:
• Is an adult patient with a confirmed diagnosis of T2DM
• Has a hemoglobin A1c (HbA1c) ≥7% to \<10.5%
• Has a BMI of ≥25 kg/m\^2 and \<45 kg/m\^2
• Is on a stable dose of either metformin or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
Locations
United States
California
Clinical Trial Site
COMPLETED
Montclair
Washington, D.c.
Clinical Trial Site
COMPLETED
Washington D.c.
Florida
Clinical Trial Site
COMPLETED
Miami
North Carolina
Clinical Trial Site
COMPLETED
Monroe
New Jersey
Clinical Trial Site
COMPLETED
Marlton
Texas
Clinical Trial Site
COMPLETED
Dallas
Clinical Trial Site
COMPLETED
Dallas
Other Locations
Argentina
Clinical Trial Site
COMPLETED
Buenos Aires
Clinical Trial Site
COMPLETED
Buenos Aires
Clinical Trial Site
COMPLETED
Buenos Aires
Clinical Trial Site
COMPLETED
San Miguel De Tucumán
Canada
Clinical Trial Site
COMPLETED
Concord
Clinical Trial Site
RECRUITING
Mount Royal
Clinical Trial Site
COMPLETED
Vancouver
Chile
Clinical Trial Site
COMPLETED
Santiago
Clinical Trial Site
COMPLETED
Santiago
Clinical Trial Site
COMPLETED
Santiago
Germany
Clinical Trial Site
COMPLETED
Essen
Poland
Clinical Trial Site
COMPLETED
Gdansk
Clinical Trial Site
COMPLETED
Tarnów
Clinical Trial Site
COMPLETED
Warsaw
Clinical Trial Site
COMPLETED
Wroclaw
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: 2025-03-03
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 144
Treatments
Experimental: Part A: ALN-4324
Participants will be administered a single dose of ALN-4324.
Placebo_comparator: Part A: Placebo
Participants will be administered a single dose of placebo.
Experimental: Part B: ALN-4324
Participants will be administered multiple doses of ALN-4324
Placebo_comparator: Part B: Placebo
Participants will be administered multiple doses of placebo
Related Therapeutic Areas
Sponsors
Leads: Alnylam Pharmaceuticals