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
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 obesity
Started Jun 2026
Typical duration for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
June 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 14, 2027
June 3, 2026
May 1, 2026
1.5 years
May 29, 2026
May 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Adverse Events
Up to 12 months
Secondary Outcomes (2)
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
Study Arms (2)
ALN-6222
EXPERIMENTALParticipants will be administered a single dose of ALN-6222.
Placebo
PLACEBO COMPARATORParticipants will be administered a single dose of placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Is an adult patient with a body mass index ≥30 kg/m\^2 to \<40 kg/m\^2
- Has a hemoglobin A1c \<6.5%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Site
Mount Royal, H3P 3P1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Alnylam Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 3, 2026
Study Start
June 3, 2026
Primary Completion (Estimated)
December 14, 2027
Study Completion (Estimated)
December 14, 2027
Last Updated
June 3, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share