ObesityPhase 1/2NCT07463846
A Study to Evaluate ALN-2232 in Participants With Obesity
A Phase 1/2 study testing ALN-2232 and Tirzepatide in people with Obesity, run by Alnylam Pharmaceuticals at 1 site in Canada.
Trial summary
The purpose of this study is to: 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ALN-2232 and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2026to 28 Apr 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
The purpose of this study is to:
- 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
- Conditions
- Obesity
- Being tested
- ALN-2232, Placebo, Tirzepatide
- Keywords
- siRNA, RNAi therepeutic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN-2232Drug
ALN-2232 will be administered subcutaneously (SC)
PlaceboDrug
Placebo will be administered SC
TirzepatideDrug
Tirzepatide will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A: ALN-2232 | Experimental | Participants will be administered a single dose of ALN-2232 Receives: Drug: ALN-2232 |
| Part A: Placebo | Placebo comparator | Participants will be administered a single dose of placebo Receives: Drug: Placebo |
| Part B: ALN-2232 | Experimental | Participants will be administered multiple doses of ALN-2232 Receives: Drug: ALN-2232 |
| Part B: Placebo | Placebo comparator | Participants will be administered multiple doses of placebo Receives: Drug: Placebo |
| Part C: ALN-2232 | Experimental | Participants will be administered multiple doses of ALN-2232 Receives: Drug: ALN-2232; Drug: Tirzepatide |
| Part C: Placebo | Placebo comparator | Participants will be administered multiple doses of placebo Receives: Drug: Placebo |
| Part C: Tirzepatide | Other | Participants will be administered multiple doses of tirzepatide once weekly Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Frequency of Adverse Events (AEs)
Measured: Up to 12 months
Part B: Percent Change from Baseline in Body Weight
Measured: Baseline up to Month 6
Part C: Percent Change from Baseline in Body Weight
Measured: Baseline up to Month 6
Secondary outcomes (9)
Part A: Change from Baseline in Proteins in Adipose Tissue
Measured: Baseline up to Month 12
Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma
Measured: Predose and up to 15 days postdose
Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma
Measured: Predose and up to 15 days postdose
Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma
Measured: Predose and up to 15 days postdose
Part A: Fraction of ALN-2232 excreted in urine
Measured: Predose and up to 8 days postdose (fe)
Part A: Percent Change from Baseline in Body Weight
Measured: Baseline up to Month 12
Part B and Part C: Concentrations of ALN-2232 in Plasma
Measured: Predose and up to 6 months postdose
Part B and Part C: Percent Change from Baseline in Body Weight
Measured: Baseline up to Month 12
Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass
Measured by dual x-ray absorptiometry (DXA)
Measured: Baseline up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start2 Mar 2026
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Alnylam PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alnylam Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Alnylam Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463846
- Sponsor's protocol ID
- ALN-2232-001
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.