First-in-human test of ALN-6222 in adults with obesity
Official title: 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
Run by Alnylam Pharmaceuticals · NCT07624071 · Data updated 2026-11-12
A first-in-human, randomized, placebo-controlled study will test a subcutaneous injection of ALN-6222 in adults with obesity to see if it is safe, tolerated, and how the body processes and responds to it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Mount Royal) |
| Status | Recruiting |
| Started | June 4, 2026 |
| Main results expected | December 14, 2027 |
| Study ends | December 14, 2027 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07624071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI 30-39.9 kg/m^2 and HbA1c <6.5% who meet safety criteria and do not have significant liver/kidney disease or active infections.
✕Probably not a fit
Individuals outside the BMI range, with liver/kidney dysfunction, active viral infections, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ALN-6222, an RNAi therapeutic, in adults with obesity. Participants will receive a single SC dose of ALN-6222 or placebo and will be monitored for adverse events, PK/PD measures, and early signals of weight or metabolic response. The trial will establish safe dosing ranges and provide early data on how the drug behaves in the body and affects obesity-related biomarkers. Inclusion requires BMI 30-39.9 kg/m^2 and HbA1c <6.5%, while several liver, kidney, and infectious disease exclusions apply. The sponsor is Alnylam Pharmaceuticals, with a clinical trial site located at Mount Royal.
Why it matters
Potential benefit: If successful, ALN-6222 could offer a new therapeutic approach for obesity by targeting disease pathways with RNAi.
How similar studies have gone: RNAi therapies have shown safety and pharmacodynamic activity in early trials, but this specific approach in obesity is investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Clinical Trial Site
Mount Royal, Canada Recruiting
Study contacts
- Study coordinator: Alnylam Clinical Trial Information Line
- Email: clinicaltrials@alnylam.com
- Phone: 1-877-ALNYLAM
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.