A Study to Evaluate ALN-6222 in Participants With Obesity

NCT07624071 — Phase 1, Recruiting, 88 participants, Alnylam Pharmaceuticals

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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

Registry	NCT07624071
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	88 (Estimated)
Sponsor	Alnylam Pharmaceuticals (Industry)
Conditions	Obesity
Interventions	ALN-6222, Placebo (Drug)
Dates	start 2026-06-04, primary completion 2027-12-14 (estimated), completion 2027-12-14 (estimated), first posted 2026-06-03, last updated 2026-10-21
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ALN-6222	Experimental	Drug: ALN-6222	Participants will be administered a single dose of ALN-6222.
Placebo	Placebo comparator	Drug: Placebo	Participants will be administered a single dose of placebo.

ALN-6222 (Drug): ALN-6222 will be administered subcutaneously (SC).
Placebo (Drug): Placebo will be administered SC.

+Outcome measures

Primary outcomes

Frequency of Adverse Events [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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Clinical Trial Site	Mount Royal	Canada	Recruiting

+Investigators

Medical Director, Study director, Alnylam Pharmaceuticals