NCT07463846

Brief 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 safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_1 obesity

Timeline
21mo left

Started Mar 2026

Typical duration for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 2, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2028

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

March 6, 2026

Last Update Submit

May 12, 2026

Conditions

Obesity

Keywords

siRNA, RNAi therepeutic

Outcome Measures

Primary Outcomes (3)

  • Part A: Frequency of Adverse Events (AEs)

    Up to 12 months

  • Part B: Percent Change from Baseline in Body Weight

    Baseline up to Month 6

  • Part C: Percent Change from Baseline in Body Weight

    Baseline up to Month 6

Secondary Outcomes (9)

  • Part A: Change from Baseline in Proteins in Adipose Tissue

    Baseline up to Month 12

  • Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma

    Predose and up to 15 days postdose

  • Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma

    Predose and up to 15 days postdose

  • Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma

    Predose and up to 15 days postdose

  • Part A: Fraction of ALN-2232 excreted in urine

    Predose and up to 8 days postdose (fe)

  • +4 more secondary outcomes

Study Arms (7)

Part A: ALN-2232

EXPERIMENTAL

Participants will be administered a single dose of ALN-2232

Drug: ALN-2232

Part A: Placebo

PLACEBO COMPARATOR

Participants will be administered a single dose of placebo

Drug: Placebo

Part B: ALN-2232

EXPERIMENTAL

Participants will be administered multiple doses of ALN-2232

Drug: ALN-2232

Part B: Placebo

PLACEBO COMPARATOR

Participants will be administered multiple doses of placebo

Drug: Placebo

Part C: ALN-2232

EXPERIMENTAL

Participants will be administered multiple doses of ALN-2232

Drug: ALN-2232Drug: Tirzepatide

Part C: Placebo

PLACEBO COMPARATOR

Participants will be administered multiple doses of placebo

Drug: Placebo

Part C: Tirzepatide

OTHER

Participants will be administered multiple doses of tirzepatide once weekly

Drug: Tirzepatide

Interventions

PlaceboDRUG

Placebo will be administered SC

Part A: PlaceboPart B: PlaceboPart C: Placebo
TirzepatideDRUG

Tirzepatide will be administered SC

Part C: ALN-2232Part C: Tirzepatide
ALN-2232DRUG

ALN-2232 will be administered subcutaneously (SC)

Part A: ALN-2232Part B: ALN-2232Part C: ALN-2232

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Site

Mount Royal, H3P 3P1, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Officials

  • Medical Director

    Alnylam Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Alnylam Clinical Trial Information Line

CONTACT

1-877-ALNYLAMclinicaltrials@alnylam.com

Alnylam Clinical Trial Information Line

CONTACT

1-877-256-9526clinicaltrials@alnylam.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

April 27, 2027

Study Completion (Estimated)

March 2, 2028

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Locations

CA(1)