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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07463846
- Acronym / sponsor ID
- ALN-2232-001
- Conditions
- Obesity
- Keywords
- siRNA, RNAi therepeutic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Alnylam PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: ALN-2232 | Experimental | Drug: ALN-2232Participants will be administered a single dose of ALN-2232 |
| Part A: Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered a single dose of placebo |
| Part B: ALN-2232 | Experimental | Drug: ALN-2232Participants will be administered multiple doses of ALN-2232 |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered multiple doses of placebo |
| Part C: ALN-2232 | Experimental | Drug: ALN-2232, Drug: TirzepatideParticipants will be administered multiple doses of ALN-2232 |
| Part C: Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered multiple doses of placebo |
| Part C: Tirzepatide | Other | Drug: TirzepatideParticipants will be administered multiple doses of tirzepatide once weekly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has a body mass index (BMI) of ≥30 kg/m^2 and <40 kg/m^2
- Has a hemoglobin A1c (HbA1c) <6.5%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALN-2232ALN-2232 will be administered subcutaneously (SC) | Drug | Part A: ALN-2232, Part B: ALN-2232, Part C: ALN-2232 |
| PlaceboPlacebo will be administered SC | Drug | Part A: Placebo, Part B: Placebo, Part C: Placebo |
| TirzepatideTirzepatide will be administered SC | Drug | Part C: ALN-2232, Part C: Tirzepatide |
Primary outcome
Part A: Frequency of Adverse Events (AEs)
Time frame: Up to 12 months
Part B: Percent Change from Baseline in Body Weight
Time frame: Baseline up to Month 6
Part C: Percent Change from Baseline in Body Weight
Time frame: Baseline up to Month 6
9 secondary outcomes
Part A: Change from Baseline in Proteins in Adipose Tissue
Time frame: Baseline up to Month 12
Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma
Time frame: Predose and up to 15 days postdose
Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma
Time frame: Predose and up to 15 days postdose
Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma
Time frame: Predose and up to 15 days postdose
Part A: Fraction of ALN-2232 excreted in urine
Time frame: Predose and up to 8 days postdose (fe)
Part A: Percent Change from Baseline in Body Weight
Time frame: Baseline up to Month 12
Part B and Part C: Concentrations of ALN-2232 in Plasma
Time frame: Predose and up to 6 months postdose
Part B and Part C: Percent Change from Baseline in Body Weight
Time frame: Baseline up to Month 12
Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass
Time frame: Baseline up to Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Alnylam Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALN-2232 and Tirzepatide in people with Obesity, run by Alnylam Pharmaceuticals at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alnylam Clinical Trial Information Line (1-877-ALNYLAM, clinicaltrials@alnylam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Frequency of Adverse Events (AEs) (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.