Clinical Trials in Poland / NCT06845202
Active, not recruiting
Phase 1/2
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
NCT06845202 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Obese or Overweight Healthy VolunteersType 2 Diabetes Mellitus (T2DM)
Investigational drug(s) / intervention(s)
ALN-4324 →Placebo
ALN-4324: ALN-4324 will be administered subcutaneously (SC)
Placebo: Placebo will be administered SC
Study summary
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
Eligibility
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
Primary outcome measure(s)
- Part A: Frequency of Adverse Events (AEs) — Up to 9 months
- Part B: Frequency of Adverse Events — Up to 12 months
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Trial Site | Montclair | California | |
| Clinical Trial Site | Washington D.C. | District of Columbia | |
| Clinical Trial Site | Miami | Florida | |
| Clinical Trial Site | Marlton | New Jersey | |
| Clinical Trial Site | Monroe | North Carolina | |
| Clinical Trial Site | Dallas | Texas | |
| Clinical Trial Site | Dallas | Texas | |
| Clinical Trial Site | Buenos Aires | Argentina | |
| Clinical Trial Site | Buenos Aires | Argentina | |
| Clinical Trial Site | Buenos Aires | Argentina | |
| Clinical Trial Site | San Miguel de Tucumán | Argentina | |
| Clinical Trial Site | Concord | Canada | |
| Clinical Trial Site | Mount Royal | Canada | |
| Clinical Trial Site | Vancouver | Canada | |
| Clinical Trial Site | Santiago | Chile | |
| Clinical Trial Site | Santiago | Chile | |
| Clinical Trial Site | Santiago | Chile | |
| Clinical Trial Site | Essen | Germany | |
| Clinical Trial Site | Gdansk | Poland | |
| Clinical Trial Site | Tarnów | Poland | |
| Clinical Trial Site | Warsaw | Poland | |
| Clinical Trial Site | Wroclaw | Poland |
More Alnylam Pharmaceuticals trials in Poland
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06845202 on ClinicalTrials.gov ↗ ← All trials in Poland