A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519005-35-00

Enrollment

Registered

2026-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Brief summary

Frequency of AEs. Safety will also be evaluated through vital signs, ECGs, and clinical laboratory assessments.

Detailed description

Change from baseline in HbA1c at Month 6., HOMA-IR, Matsuda index, and glucose AUC response to glucose tolerance test., Plasma concentrations of ALN-4324 and potential metabolite(s).

Interventions

DRUGPhosphate buffered saline for SC administration

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency of AEs. Safety will also be evaluated through vital signs, ECGs, and clinical laboratory assessments.	—

Secondary

Measure	Time frame
Change from baseline in HbA1c at Month 6., HOMA-IR, Matsuda index, and glucose AUC response to glucose tolerance test., Plasma concentrations of ALN-4324 and potential metabolite(s).	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 11, 2026