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

Part of paid clinical trials in Montclair, California.

Sponsor
Alnylam Pharmaceuticals
Study ID
NCT06845202
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obese or Overweight Healthy Volunteers
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • ALN-4324 — DRUG
    ALN-4324 will be administered subcutaneously (SC)
  • Placebo — DRUG
    Placebo will be administered SC

Study Details

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, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Key Dates

Start date
Mar 3, 2025
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: ALN-4324
    Participants will be administered a single dose of ALN-4324.
  • Placebo Comparator: Part A: Placebo
    Participants will be administered a single dose of placebo.
  • Experimental: Part B: ALN-4324
    Participants will be administered multiple doses of ALN-4324
  • Placebo Comparator: Part B: Placebo
    Participants will be administered multiple doses of placebo

Primary Outcome Measure

Part A: Frequency of Adverse Events (AEs) [ Time Frame: Up to 9 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Clinical Trial SiteMontclairCalifornia91763-
Clinical Trial SiteWashington D.C.District of Columbia20009-
Clinical Trial SiteMiamiFlorida33126-
Clinical Trial SiteMarltonNew Jersey08053-
Clinical Trial SiteMonroeNorth Carolina28112-
Clinical Trial SiteDallasTexas75230-
Clinical Trial SiteDallasTexas75246-

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Clinical Trial Site· Montclair, CAClinical Trial Site· Washington D.C., DCClinical Trial Site· Miami, FLClinical Trial Site· Marlton, NJClinical Trial Site· Monroe, NCClinical Trial Site· Dallas, TX

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