A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus
Purpose
The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM
Condition
- Type 2 Diabetes Mellitus (T2DM)
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Is an adult patient with a confirmed diagnosis of T2DM - Has a body mass index (BMI) of ≥25 kg/m^2 and <39.9 kg/m^2 - Has a hemoglobin A1c (HbA1c) ≥6.5% to <10.5% - Is on a stable dose of metformin
Exclusion Criteria
- 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 known to interfere with glucose or insulin metabolism other than current treatment for T2DM or birth control methods Note: other protocol defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ALN-4324 |
Participants will be administered a single dose of ALN-4324. |
|
|
Placebo Comparator Placebo |
Participants will be administered a single dose of placebo. |
|
Recruiting Locations
Clinical Trial Site
Chula Vista, California 91911
Chula Vista, California 91911
More Details
- Status
- Recruiting
- Sponsor
- Alnylam Pharmaceuticals