Status:
RECRUITING
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Obese or Overweight Healthy Volunteers
Type 2 Diabetes Mellitus (T2DM)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 e...
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Part A:
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
Part B:
- Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i
Note: other protocol defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06845202
Start Date
March 3 2025
End Date
August 31 2027
Last Update
April 17 2026
Active Locations (20)
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1
Clinical Trial Site
Montclair, California, United States, 91763
2
Clinical Trial Site
Washington D.C., District of Columbia, United States, 20009
3
Clinical Trial Site
Miami, Florida, United States, 33126
4
Clinical Trial Site
Marlton, New Jersey, United States, 08053