NCT06845202Active, not recruitingPhase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
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)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 20 Feb 2025
- Start date
- 3 Mar 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Alnylam Pharmaceuticals
- Diseases
- Obesity, Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06845202
- EU CT number
- 2024-519005-35-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 105
- From 3 Mar 2025 to the primary completion date, 31 Aug 2027
- 18 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i
- Note: other protocol defined inclusion/exclusion criteria apply
Other illness
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Part B:
Other
- Part A:
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Concord | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Mount Royal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Studienzentrum Bocholderstrasse Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Medizentrum Essen Borbeck Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Metabolica Sp. z o.o. Coordinator of this site? Confirm its status | Tarnów | Poland | Active, not recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Montclair | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.