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 (19) 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
NOT_YET_RECRUITING
Montclair
Washington, D.c.
Clinical Trial Site
NOT_YET_RECRUITING
Washington D.c.
Florida
Clinical Trial Site
NOT_YET_RECRUITING
Miami
North Carolina
Clinical Trial Site
NOT_YET_RECRUITING
Monroe
Clinical Trial Site
NOT_YET_RECRUITING
Raleigh
New Jersey
Clinical Trial Site
NOT_YET_RECRUITING
Berlin
Other Locations
Argentina
Clinical Trial Site
NOT_YET_RECRUITING
Buenos Aires
Clinical Trial Site
NOT_YET_RECRUITING
Mar Del Plata
Clinical Trial Site
NOT_YET_RECRUITING
San Miguel De Tucumán
Canada
Clinical Trial Site
NOT_YET_RECRUITING
Concord
Clinical Trial Site
RECRUITING
Laval
Clinical Trial Site
NOT_YET_RECRUITING
Mount Royal
Clinical Trial Site
NOT_YET_RECRUITING
Vancouver
Chile
Clinical Trial Site
NOT_YET_RECRUITING
Santiago
Germany
Clinical Trial Site
NOT_YET_RECRUITING
Essen
Poland
Clinical Trial Site
NOT_YET_RECRUITING
Gdansk
Clinical Trial Site
NOT_YET_RECRUITING
Lublin
Clinical Trial Site
NOT_YET_RECRUITING
Tarnów
Clinical Trial Site
NOT_YET_RECRUITING
Warsaw
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