Health TrialsbyHealthPanel

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

ConditionsObese or Overweight Healthy VolunteersType 2 Diabetes Mellitus (T2DM)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlnylam Pharmaceuticals

About this trial

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, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Has a body mass index (BMI) of ≥27 kg/m² and <40 kg/m²

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/m² and <45 kg/m²

Disqualifiers

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALN-4324

    Drug

    ALN-4324 will be administered subcutaneously (SC)

  • Placebo

    Drug

    Placebo will be administered SC

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: Part A: ALN-4324Experimental treatment 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: ALN-4324Experimental treatment 1 intervention
Group D: Part B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alnylam Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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