Obesity / ALN-6222 · Phase 1 Trial

A Study to Evaluate ALN-6222 in Participants With Obesity

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a first-in-human, Phase 1 safety and tolerability study of ALN-6222, an investigational subcutaneous drug for obesity. No efficacy or safety results have been posted in this registry record; the trial is currently recruiting.

What was studied

Phase 1, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Obesity; age from 18 Years; to 65 Years. Intervention: ALN-6222. Compared with: Placebo — Placebo Comparator. n = 88. 1 site: Canada.

Key findings

Safety

This is a registry record with no posted results; no safety, tolerability, pharmacokinetic, pharmacodynamic, or efficacy data are reported. Phase 1 study; findings will be preliminary and focused on dose escalation and safety, not clinical benefit.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

First-in-human Phase 1 trial with safety and tolerability as primary outcomes; no efficacy results are posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Frequency of Adverse Events (assessed at Up to 12 months)

DesignPhase 1, Interventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationObesity; age from 18 Years; to 65 Years

Sample size88

InterventionALN-6222

ComparatorPlacebo — Placebo Comparator

Setting1 site: Canada

Reported figures

Quoted from the source exactly as published.

Planned sample size88

Study phasePhase 1

Primary outcome measureFrequency of Adverse Events, Up to 12 months

Recruitment statusRECRUITING

Caveats

This is a registry record with no posted results; no safety, tolerability, pharmacokinetic, pharmacodynamic, or efficacy data are reported.
Phase 1 study; findings will be preliminary and focused on dose escalation and safety, not clinical benefit.
Single ascending dose design limits assessment of repeat dosing.
No comparator arm details or prior mechanistic data provided in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, double-blind, placebo-controlled, single ascending dose Phase 1.

Directness

limited

Primary outcome is safety/tolerability; efficacy not yet measured or reported.

Consistency

insufficient

First-in-human study; no prior data to compare against.

Risk of bias

moderate

Double-blind design reduces bias; small Phase 1 cohort limits generalizability.

Sample adequacy

limited

88 estimated participants across ascending dose groups typical for Phase 1.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07624071). This is a study registration, not published results. Lead sponsor: Alnylam Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 88 participants (ESTIMATED). Conditions: Obesity. Interventions: DRUG: ALN-6222; DRUG: Placebo. Primary outcome measures: Frequency of Adverse Events , Up to 12 months. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityALN-6222NCT07624071Alnylam Pharmaceuticals