NCT07624071RecruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ALN-6222 in Adult Participants With Obesity
Alnylam Pharmaceuticals1 site in 1 country88 target enrollmentStarted: June 4, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Frequency of Adverse Events
Study Overview
Brief Summary
This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants with obesity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is an adult patient with a body mass index ≥30 kg/m^2 to <40 kg/m^2
- •Has a hemoglobin A1c <6.5%
Exclusion Criteria
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)
- •Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- •Has an estimated glomerular filtration (eGFR) of <60 mL/min/1.73m^2 at screening
- •Note: other protocol defined inclusion / exclusion criteria apply
Arms & Interventions
ALN-6222
Experimental
Participants will be administered a single dose of ALN-6222.
Intervention: ALN-6222 (Drug)
Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Frequency of Adverse Events
Time Frame: Up to 12 months
Secondary Outcomes
- Concentrations of ALN-6222 in Plasma(Predose and up to 3 days postdose)
- Change from Baseline Protein Markers in Plasma(Predose and up to 12 months postdose)
Investigators
Study Sites (1)
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