Tests ALN-2232, alone or with tirzepatide, in adults with obesity
Tests ALN-2232, alone or with tirzepatide, in adults with obesity.
Key facts
- Who runs it
- Alnylam Pharmaceuticals
- Where
- Mount Royal, CanadaSee the site
- Trial code
- Registry title
- A Study to Evaluate ALN-2232 in Participants With Obesity
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 156 people, planned
- Started
- 2 Mar 2026
- Expected to end
- 28 Apr 2028
- Type of study
- Interventional, 7 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ALN-2232
- Placebo
- Tirzepatide
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with obesity. It tests the safety and effects of ALN-2232, alone or started together with tirzepatide.
- Age
- 18 Years to 65 Years
- Sex
- All sexes can join.
- Disease stage
- Obesity with a body mass index (BMI) of ≥30 kg/m^2 and <40 kg/m^2.
- Earlier treatment
- People currently receiving therapies for chronic weight management or antidiabetic medications cannot join.
- Biomarker or test result
- Hemoglobin A1c (HbA1c) must be <6.5% (48 mmol/mol).
Main reasons for not taking part
- Any clinically significant disease, medical condition, or abnormal lab result that could compromise safety or confound the study results
- Currently receiving therapies for chronic weight management
- Currently taking antidiabetic medications
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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%
Who cannot take part
- Receiving therapies for chronic weight management or antidiabetic medications; Note: other protocol defined inclusion/exclusion criteria apply
- Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results
- All Parts:
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Canada
- Mount RoyalHospital not named in the registryTaking people
About the trial
What the trial wants to find out
The purpose of this study is to:
Read full original descriptionShow less
* evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity
The 7 groups in the trial
- Part A: ALN-2232Treatment being tested
Participants will be administered a single dose of ALN-2232
Treatment: ALN-2232
- Part A: PlaceboPlacebo, for comparison
Participants will be administered a single dose of placebo
Treatment: Placebo
- Part B: ALN-2232Treatment being tested
Participants will be administered multiple doses of ALN-2232
Treatment: ALN-2232
- Part B: PlaceboPlacebo, for comparison
Participants will be administered multiple doses of placebo
Treatment: Placebo
- Part C: ALN-2232Treatment being tested
Participants will be administered multiple doses of ALN-2232
Treatment: ALN-2232 and Tirzepatide
- Part C: PlaceboPlacebo, for comparison
Participants will be administered multiple doses of placebo
Treatment: Placebo
- Part C: TirzepatideOther group
Participants will be administered multiple doses of tirzepatide once weekly
Treatment: Tirzepatide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests ALN-2232, alone or with tirzepatide, in adults with obesityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07463846, who can take part
- Record updated
- 12 November 2026