Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06845202 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 1/2
Started2025-03-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 27% 144 → 105 participants
See other at-risk trials from Alnylam Pharmaceuticals

Amendment history

2026-08-12
Study Status v16
Re-verified, no change to tracked fields
2026-07-22
Study Status, Study Description, Study Design, Contacts/Locations v15
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 144 → 105 participants
Study sitesdetails revised at 22 of 22 sites
2026-06-10
Study Status, Contacts/Locations v14
Study sitesdetails revised at 21 of 22 sites
2026-05-12
Study Status, Contacts/Locations v13
Study sites20→22
2026-04-16
Study Status, Contacts/Locations v12
Trial sites expanded: 2 → 20 locations
Show 11 earlier versions
2026-03-30
Study Status v11
Re-verified, no change to tracked fields
2026-02-19
Study Status, Contacts/Locations v10
Study sites24→2
2025-12-18
Study Status, Contacts/Locations v9
Study sites18→24
2025-11-10
Study Status v8
Re-verified, no change to tracked fields
2025-10-16
Study Status, Contacts/Locations v7
Study sites19→18
2025-09-29
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v6
PhasePhase 1→Phase 1/2
Primary completion date2026-06-30→2027-08-31
Completion date2026-06-30→2027-08-31
Enrollment target84→144
Study sites1→19
Study arms2→4
Eligibility criteria+388 characters
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 k [...] 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 SG [...] [...]
Secondary endpoints4 to 7 entries
Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma Part A: Fraction of ALN-4324 excreted in urine Part B: Change from Baseline in HbA1c Part B: Response to Glucose Tolerance Test Part B: Concentrations of ALN-4324 in Plasma
Primary endpoints1 to 2 entries
Part A: Frequency of Adverse Events (AEs) Part B: Frequency of Adverse Events
Study title+38 characters
A Phase 1 Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
2025-07-15
3 amendments v3-v5
3 re-verifications since 2025-05-07, no change to tracked fields
2025-04-01
Study Status v2
Start date2025-03-04→2025-03-03
2025-04-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-03→confirmed 2025-03-04
Study sites0→1
2025-02-20
Original filing
Alnylam Pharmaceuticals
31 trials monitored
See 5 trials at risk
Diabetes
4,247 trials monitored
See 176 trials at risk
Obesity
3,523 trials monitored
See 133 trials at risk
Type 2 Diabetes
2,082 trials monitored
See 101 trials at risk
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
Trial Details
NCT Number NCT06845202
Lead Sponsor Alnylam Pharmaceuticals
Conditions Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
Enrollment 105 participants
Start Date 2025-03-03
Primary Completion 2027-08-31 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-16