A Phase 1 Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers

Phase 1

Recruiting

• Conditions: Obese or Overweight Healthy Volunteers
• Interventions: Drug: ALN-4324; Drug: Placebo

• Registration Number: NCT06845202
• Lead Sponsor: Alnylam Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-25
• Study Start: 2025-03-03
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Has a body mass index (BMI) of ≥27 kg/m^2 and <40 kg/m^2

Exclusion Criteria

• Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

Note: other protocol defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALN-4324	ALN-4324	Participants will be administered a single dose of ALN-4324.
Placebo	Placebo	Participants will be administered a single dose of placebo.

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs)	Up to 9 months

Secondary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma	Predose and up to 3 days postdose
Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma	Predose and up to 3 days postdose
Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma	Predose and up to 3 days postdose
Fraction of ALN-4324 excreted in urine	Predose and up to 24 hours postdose (fe)

Trial Locations

Locations (1)

Clinical Trial Site; 🇨🇦 Laval, Quebec, Canada