Actively Recruiting
A Phase 1/2 Study of Safety, Tolerability, and Effects of Single and Multiple Doses of ALN-4324 in Overweight to Obese Adults With and Without Type 2 Diabetes Mellitus
Led by Alnylam Pharmaceuticals · Updated on 2026-05-14
144
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and effects of ALN-4324 in overweight to obese adults. The study has two parts: one in healthy volunteers and another in adults with type 2 diabetes mellitus (T2DM). It aims to understand how the drug behaves in the body and its impact on blood sugar control and other health measures. Participants in the first part receive a single dose of ALN-4324 or a placebo, given as an injection under the skin. In the second part, adults with T2DM receive multiple doses of ALN-4324 or placebo, also by injection. The study uses a randomized, double-blind design, meaning participants are randomly assigned to groups and neither they nor the researchers know who receives the drug or placebo during the trial. During the study, participants will be monitored for side effects and how their bodies process the drug. Blood tests will measure drug levels and effects on blood sugar control, including hemoglobin A1c and glucose tolerance. The study lasts up to 12 months, with assessments at various times depending on the part. Safety and how well participants tolerate the drug are the main outcomes being measured.
CONDITIONS
Brief Title
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Part A: Body mass index (BMI) of 27 to less than 40 kg/m²
- For Part B: Confirmed diagnosis of type 2 diabetes mellitus
- For Part B: Hemoglobin A1c between 7% and less than 10.5%
- For Part B: Body mass index (BMI) of 25 to less than 45 kg/m²
- For Part B: On a stable dose of metformin or metformin plus a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
- Age between 18 and 75 years
You will not qualify if you...
- For Part A: Known HIV infection or current/chronic hepatitis B or C infection
- For Part B: Receiving treatments for weight management or antidiabetic medications other than metformin and SGLT2i
- Other protocol defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months depending on dosing schedule
Participants receive either a single dose or multiple doses of ALN-4324 or placebo administered subcutaneously.
Multiple visits for dosing and assessments up to 12 months
Duration - Up to 12 months
Participants are monitored for safety and treatment effects after dosing completion.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 22 locations
1
Clinical Trial Site
Montclair, California, United States, 91763
Actively Recruiting
2
Clinical Trial Site
Washington D.C., District of Columbia, United States, 20009
Not Yet Recruiting
3
Clinical Trial Site
Miami, Florida, United States, 33126
Actively Recruiting
4
Clinical Trial Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
5
Clinical Trial Site
Monroe, North Carolina, United States, 28112
Actively Recruiting
6
Clinical Trial Site
Dallas, Texas, United States, 75230
Actively Recruiting
7
Clinical Trial Site
Dallas, Texas, United States, 75246
Actively Recruiting
8
Clinical Trial Site
Buenos Aires, Argentina, C1060
Actively Recruiting
9
Clinical Trial Site
Buenos Aires, Argentina, C1061AAE
Actively Recruiting
10
Clinical Trial Site
Buenos Aires, Argentina, C1061
Actively Recruiting
11
Clinical Trial Site
San Miguel de Tucumán, Argentina, T4000IHE
Actively Recruiting
12
Clinical Trial Site
Concord, Canada, L4K 4M2
Actively Recruiting
13
Clinical Trial Site
Mount Royal, Canada, H3P 3P1
Actively Recruiting
14
Clinical Trial Site
Vancouver, Canada, V5Y 3W2
Not Yet Recruiting
15
Clinical Trial Site
Santiago, Chile, 7500710
Not Yet Recruiting
16
Clinical Trial Site
Santiago, Chile, 7770086
Not Yet Recruiting
17
Clinical Trial Site
Santiago, Chile, 8320000
Actively Recruiting
18
Clinical Trial Site
Essen, Germany, 45355
Actively Recruiting
19
Clinical Trial Site
Gdansk, Poland, 80-546
Actively Recruiting
20
Clinical Trial Site
Tarnów, Poland, 33-100
Not Yet Recruiting
21
Clinical Trial Site
Warsaw, Poland, 02-507
Actively Recruiting
22
Clinical Trial Site
Wroclaw, Poland, 51-162
Actively Recruiting
Research Team
A
Alnylam Clinical Trial Information Line
A
Alnylam Clinical Trial Information Line
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here