Obesity / Tirzepatide / ALN-2232 · Phase 1/2 Trial

A Study to Evaluate ALN-2232 in Participants With Obesity

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry entry for an ongoing Phase 1/2 study of ALN-2232, a novel investigational agent, in patients with obesity. The study plans to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (measured by percent change in body weight) across single ascending doses, multiple doses, and combination with tirzepatide. No results are reported in this registry record.

What was studied

Phase 1/2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Obesity; age from 18 Years; to 65 Years. Intervention: Part A: ALN-2232; Part B: ALN-2232; Part C: ALN-2232; Part C: Tirzepatide. Compared with: Part A: Placebo — Placebo Comparator; Part B: Placebo — Placebo Comparator; Part C: Placebo — Placebo Comparator. n = 156. 1 site: Canada.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1/2 registry record for a planned interventional study with no results reported; enrollment is ongoing and no efficacy or safety data are available.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Part A: Frequency of Adverse Events (AEs) (assessed at Up to 12 months); Part B: Percent Change from Baseline in Body Weight (assessed at Baseline up to Month 6); Part C: Percent Change from Baseline in Body Weight (assessed at Baseline up to Month 6)

DesignPhase 1/2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose

PopulationObesity; age from 18 Years; to 65 Years

Sample size156

InterventionPart A: ALN-2232; Part B: ALN-2232; Part C: ALN-2232; Part C: Tirzepatide

ComparatorPart A: Placebo — Placebo Comparator; Part B: Placebo — Placebo Comparator; Part C: Placebo — Placebo Comparator

Setting1 site: Canada

Reported figures

Quoted from the source exactly as published.

Estimated enrollment156

Study phasePhase 1, Phase 2

Primary outcome measure (Part A)Frequency of Adverse Events, up to 12 months

Primary outcome measure (Parts B and C)Percent Change from Baseline in Body Weight, baseline up to month 6

Caveats

This is a registry record only; no efficacy or safety results are reported.
Recruitment status is ongoing; the study is not yet complete.
Full methods, randomization approach, and blinding strategy are not detailed in this registry extract.
No comparative effect sizes, confidence intervals, or p-values are available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1/2 interventional design with placebo control and active comparator arm.

Directness

moderate

Evaluates a novel agent in the target population (obesity); surrogate endpoints (body weight change) planned.

Consistency

insufficient

Registry record only; no results reported to assess consistency with prior work.

Risk of bias

insufficient

Study design mentions placebo control but full methods and blinding approach not detailed in registry.

Sample adequacy

limited

Estimated enrollment 156 participants across three parts; Phase 1/2 size typical for early safety work.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07463846). This is a study registration, not published results. Lead sponsor: Alnylam Pharmaceuticals. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 156 participants (ESTIMATED). Conditions: Obesity. Interventions: DRUG: ALN-2232; DRUG: Placebo; DRUG: Tirzepatide. Primary outcome measures: 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. 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityTirzepatideALN-2232NCT07463846Alnylam Pharmaceuticals