ALN-4324 / Type 2 Diabetes Mellitus (T2DM) / Obese Or Overweight Healthy Volunteers · Phase 1/2 Trial

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

ClinicalTrials.gov · August 14, 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-4324, an investigational drug for weight and glycaemic control in overweight/obese individuals and T2DM patients. No results are posted; the record documents planned enrollment, study phases, and primary safety endpoints only. Readers should not infer any efficacy or safety conclusion from this registry entry.

What was studied

Phase 1/2, Interventional, Randomized, Parallel, Triple masking, Treatment purpose. Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM); age from 18 Years; to 75 Years; accepts healthy volunteers. Intervention: Part A: ALN-4324; Part B: ALN-4324. Compared with: Part A: Placebo — Placebo Comparator; Part B: Placebo — Placebo Comparator. n = 105. 22 sites across 6 countries.

Key findings

Safety

This is a registry record with no results posted; no efficacy, safety, or pharmacokinetic data are available. Primary outcomes are safety and tolerability; no efficacy endpoint is designated as primary.

Who this may help

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

Plain-language summary

This is an active Phase 1/2 interventional trial registered before results are available; no efficacy or safety data are reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Part A: Frequency of Adverse Events (AEs) (assessed at Up to 9 months); Part B: Frequency of Adverse Events (assessed at Up to 12 months)

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

PopulationObese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM); age from 18 Years; to 75 Years; accepts healthy volunteers

Sample size105

InterventionPart A: ALN-4324; Part B: ALN-4324

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

Setting22 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment105

Study phasePhase 1/2

Primary endpoint (Part A)Frequency of Adverse Events, up to 9 months

Primary endpoint (Part B)Frequency of Adverse Events, up to 12 months

Caveats

This is a registry record with no results posted; no efficacy, safety, or pharmacokinetic data are available.
Recruitment status is ACTIVE_NOT_RECRUITING, indicating the study is ongoing but enrollment has closed.
Primary outcomes are safety and tolerability; no efficacy endpoint is designated as primary.
Sample size is modest for Phase 2 efficacy assessment and no power calculation is reported.

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 design with placebo control; single and multiple ascending dose arms planned.

Directness

moderate

Addresses safety, tolerability, and efficacy in relevant populations but study is pre-results.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Placebo-controlled design planned; no methodological detail sufficient for bias assessment.

Sample adequacy

limited

105 participants total across Phase 1 and Phase 2 arms; modest for Phase 2 efficacy.

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 (NCT06845202). This is a study registration, not published results. Lead sponsor: Alnylam Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 105 participants (ACTUAL). Conditions: Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM). Interventions: DRUG: ALN-4324; DRUG: Placebo. Primary outcome measures: Part A: Frequency of Adverse Events (AEs) , Up to 9 months; Part B: Frequency of Adverse Events , Up to 12 months. Brief summary: The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Follow from this

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

NCT06845202ALN-4324Type 2 Diabetes Mellitus (T2DM)Obese Or Overweight Healthy VolunteersAlnylam Pharmaceuticals