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NCT Number: NCT06845202

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obese or Overweight Healthy Volunteers Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Mellitus (T2DM)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clinical Trial Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Part A:

  • Has a body mass index (BMI) of ≥27 kg/m^2 and <40 kg/m^2

Part B:

  • Is an adult patient with a confirmed diagnosis of T2DM
  • Has a hemoglobin A1c (HbA1c) ≥7% to <10.5%
  • Has a BMI of ≥25 kg/m^2 and <45 kg/m^2
  • Is on a stable dose of either metformin or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i)

Exclusion criteria

Part A:

  • Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

Part B:

  • Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i

Note: other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

ALN-4324

Drug

ALN-4324 will be administered subcutaneously (SC)

Placebo

Drug

Placebo will be administered SC

Primary outcomes

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

    Time frame: Up to 9 months

  2. Part B: Frequency of Adverse Events

    Time frame: Up to 12 months

Secondary outcomes

  1. Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma

    Time frame: Predose and up to 3 days postdose

  2. Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma

    Time frame: Predose and up to 3 days postdose

  3. Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma

    Time frame: Predose and up to 3 days postdose

  4. Part A: Fraction of ALN-4324 excreted in urine

    Time frame: Predose and up to 24 hours postdose (fe)

  5. Part B: Change from Baseline in HbA1c

    Time frame: Baseline up to 6 months

  6. Part B: Response to Glucose Tolerance Test

    Time frame: Predose and up to 2 hours postdose

  7. Part B: Concentrations of ALN-4324 in Plasma

    Time frame: Predose and up to 4 hours postdose

Sponsors and collaborators

Lead sponsor

Alnylam Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2025
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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