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NCT07463846·Phase 1 / Phase 2·INTERVENTIONAL

A Study to Evaluate ALN-2232 in Participants With Obesity

TirzepatideGlucagonWeight lossRecruiting

Status

Recruiting

Phase

Phase 1 / Phase 2

Enrollment

156

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

ALN-2232

ALN-2232 will be administered subcutaneously (SC)

DRUG

Placebo

Placebo will be administered SC

DRUG

Tirzepatide

Tirzepatide will be administered SC

Timeline

From registration to results.

  1. First posted

    Mar 11, 2026

  2. Study start

    Mar 2, 2026

  3. Primary completion

    Apr 27, 2027

  4. Study completion

    Mar 2, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 23, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Measured by dual x-ray absorptiometry (DXA)

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Clinical Trial Site

Mount Royal, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsTirzepatide trial dashboard →DatabaseTirzepatide database entry →ResearchTirzepatide research guide →TrialsGlucagon trial dashboard →DatabaseGlucagon database entry →ResearchGlucagon research guide →