Health TrialsbyHealthPanel

A Study to Evaluate ALN-2232 in Participants With Obesity

ConditionObesity
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlnylam Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a body mass index (BMI) of ≥30 kg/m² and <40 kg/m²

Has a hemoglobin A1c (HbA1c) <6.5%

Disqualifiers

Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results

Receiving therapies for chronic weight management or antidiabetic medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALN-2232

    Drug

    ALN-2232 will be administered subcutaneously (SC)

  • Placebo

    Drug

    Placebo will be administered SC

  • Tirzepatide

    Drug

    Tirzepatide will be administered SC

Treatment groups

156 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part A: ALN-2232Experimental treatment 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: ALN-2232Experimental treatment 1 intervention
Group D: Part B: PlaceboPlacebo comparator 1 intervention
Group E: Part C: ALN-2232Experimental treatment 2 interventions
Group F: Part C: PlaceboPlacebo comparator 1 intervention
Group G: Part C: TirzepatideOther 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Frequency of Adverse Events (AEs)

Time frame
Up to 12 months
2

Part B: Percent Change from Baseline in Body Weight

Time frame
Baseline up to Month 6
3

Part C: Percent Change from Baseline in Body Weight

Time frame
Baseline up to Month 6

Secondary outcomes

1

Part A: Change from Baseline in Proteins in Adipose Tissue

Time frame
Baseline up to Month 12
2

Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma

Time frame
Predose and up to 15 days postdose
3

Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma

Time frame
Predose and up to 15 days postdose
4

Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma

Time frame
Predose and up to 15 days postdose

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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