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NCT Number: NCT07463846

A Study to Evaluate ALN-2232 in 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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Trial Site

Mount Royal, H3P 3P1, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALN-2232

Drug

ALN-2232 will be administered subcutaneously (SC)

Placebo

Drug

Placebo will be administered SC

Tirzepatide

Drug

Tirzepatide will be administered SC

Primary outcomes

  1. Part A: Frequency of Adverse Events (AEs)

    Time frame: Up to 12 months

  2. Part B: Percent Change from Baseline in Body Weight

    Time frame: Baseline up to Month 6

  3. Part C: Percent Change from Baseline in Body Weight

    Time frame: Baseline up to Month 6

Secondary outcomes

  1. Part A: Change from Baseline in Proteins in Adipose Tissue

    Time frame: Baseline up to Month 12

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

    Time frame: Predose and up to 15 days postdose

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

    Time frame: Predose and up to 15 days postdose

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

    Time frame: Predose and up to 15 days postdose

  5. Part A: Fraction of ALN-2232 excreted in urine

    Time frame: Predose and up to 8 days postdose (fe)

  6. Part A: Percent Change from Baseline in Body Weight

    Time frame: Baseline up to Month 12

  7. Part B and Part C: Concentrations of ALN-2232 in Plasma

    Time frame: Predose and up to 6 months postdose

  8. Part B and Part C: Percent Change from Baseline in Body Weight

    Time frame: Baseline up to Month 12

  9. Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass

    Time frame: Baseline up to Month 12

    Measured by dual x-ray absorptiometry (DXA)

Study contacts

Contact information is provided by the study sponsor or research team.

Alnylam Clinical Trial Information Line

CONTACT

[email protected]

1-877-ALNYLAM

Alnylam Clinical Trial Information Line

CONTACT

[email protected]

1-877-256-9526

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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