Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06845202

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

Led by Alnylam Pharmaceuticals · Updated on 2026-05-14

144

Participants Needed

22

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • For Part A: Body mass index (BMI) of at least 27 kg/m² and less than 40 kg/m²
  • For Part B: Adult patients with confirmed type 2 diabetes mellitus (T2DM)
  • For Part B: Hemoglobin A1c (HbA1c) between 7% and less than 10.5%
  • For Part B: BMI of at least 25 kg/m² and less than 45 kg/m²
  • For Part B: Stable dose of metformin alone or metformin with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
Not Eligible

You will not qualify if you...

  • For Part A: Known HIV infection or current/chronic hepatitis B or C infection
  • For Part B: Use of chronic weight management therapies or antidiabetic medications other than metformin and SGLT2i
  • Other protocol-defined inclusion and exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

A

Alnylam Clinical Trial Information Line

CONTACT

A

Alnylam Clinical Trial Information Line

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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