A Study to Evaluate ALN-6222 in Participants With Obesity

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07624071

Enrollment

Registered

2026-06-03

Start date

2026-06-04

Completion date

2027-12-14

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

siRNA, RNAi therapeutic

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.

Interventions

DRUGALN-6222

ALN-6222 will be administered subcutaneously (SC).

DRUGPlacebo

Placebo will be administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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 /

Design outcomes

Primary

Measure	Time frame
Frequency of Adverse Events	Up to 12 months

Secondary

Measure	Time frame
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

Countries

Canada

Contacts

CONTACTAlnylam Clinical Trial Information Line

clinicaltrials@alnylam.com1-877-ALNYLAM

STUDY_DIRECTORMedical Director

Alnylam Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026