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Evaluating ALN-4324 in overweight to obese healthy volunteers

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)

PHASE1; PHASE2 · Alnylam Pharmaceuticals · NCT06845202

This study is testing a new drug called ALN-4324 in overweight and obese healthy volunteers to see how safe it is and how it affects weight management.

Quick facts

PhasePHASE1; PHASE2
Study typeInterventional
Enrollment144 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAlnylam Pharmaceuticals (industry)
Locations20 sites (Montclair, California and 19 other locations)
Trial IDNCT06845202 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers with a body mass index (BMI) between 27 and 40 kg/m². Participants will receive either the ALN-4324 treatment or a placebo, allowing researchers to characterize the pharmacokinetics of the drug. The study is designed to gather important data on how the drug is processed in the body and its potential effects on weight management.

Who should consider this trial

Good fit: Ideal candidates are healthy volunteers with a BMI of 27 to 40 kg/m².

Not a fit: Patients with known HIV or chronic hepatitis infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic options for managing obesity.

How similar studies have performed: Other studies involving RNAi therapeutics have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Montclair, California and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus, siRNA, RNAi therepeutic

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.