Recruiting
Phase 1

ALN-6222

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT07624071

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ALN-6222

Placebo

Study Details

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.

Conditions

Obesity

Study ID

NCT07624071

Start date

Jun 4, 2026

Status verified date

Sep, 2026

Completion date

Dec 14, 2027

Anticipated

Primary completion date

Dec 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-6222

Participants will be administered a single dose of ALN-6222.

placebo comparator: Placebo

Participants will be administered a single dose of placebo.

Interventions

ALN-6222

ALN-6222 will be administered subcutaneously (SC).

Placebo

Placebo will be administered SC.

Primary outcome measure

  • Frequency of Adverse Events [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Alnylam Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

1-877-256-9526clinicaltrials@alnylam.com

Locations

Clinical Trial Site

Recruiting

Mount Royal, Canada, H3P 3P1

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • siRNA, RNAi therapeutic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-09-03.