ALN-2232 treatment for people with obesity.
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity
Run by Alnylam Pharmaceuticals · NCT07463846 · Data updated 2026-11-12
This trial will test whether ALN-2232, alone or started with tirzepatide, is safe, well tolerated, and helps people with obesity (BMI 30–<40 and HbA1c <6.5%) lose weight while measuring how the drug behaves in the body.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 156 (estimated) |
| Sponsor | Alnylam Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Mount Royal) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | April 28, 2027 |
| Study ends | April 28, 2028 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07463846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with BMI between 30 and <40 kg/m2, HbA1c under 6.5%, not taking chronic weight-management or antidiabetic medications, and without clinically significant comorbidities.
✕Probably not a fit
People with BMI outside the 30–<40 range, HbA1c ≥6.5% (diabetes), those taking chronic weight-loss or antidiabetic drugs, or those with significant other medical conditions are unlikely to qualify or 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 1/2 trial gives single ascending doses and multiple doses of ALN-2232 to adults with obesity to measure safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on weight. A separate cohort receives multiple doses of ALN-2232 co-initiated with tirzepatide to explore combination effects. Eligible participants have BMI 30 to <40 kg/m2 and HbA1c below 6.5%, and participants on chronic weight-management or antidiabetic medications are excluded. Primary outcomes emphasize safety and drug behavior, with secondary measures likely including weight change and metabolic markers.
Why it matters
Potential benefit: If successful, this approach could provide a new RNAi-based treatment that lowers weight and improves metabolic health for people with obesity.
How similar studies have gone: RNAi medicines have succeeded in other diseases, but using siRNA specifically for obesity is relatively new and clinical evidence is currently limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All Parts: * Has a body mass index (BMI) of ≥30 kg/m\^2 and \<40 kg/m\^2 * Has a hemoglobin A1c (HbA1c) \<6.5% Exclusion Criteria: All Parts: * Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results * Receiving therapies for chronic weight management or antidiabetic medications 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.