A Study to Evaluate ALN-2232 in Participants With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALN-2232, Placebo, Tirzepatide.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity
Overview
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
Interventions
- Drug ALN-2232
ALN-2232 will be administered subcutaneously (SC) - Drug Placebo
Placebo will be administered SC - Drug Tirzepatide
Tirzepatide will be administered SC
Primary outcome measures
- Part A: Frequency of Adverse Events (AEs) [Time frame: Up to 12 months]
- Part B: Percent Change from Baseline in Body Weight [Time frame: Baseline up to Month 6]
- Part C: Percent Change from Baseline in Body Weight [Time frame: Baseline up to Month 6]
Secondary outcome measures (9)
- Part A: Change from Baseline in Proteins in Adipose Tissue [Time frame: Baseline up to Month 12]
- Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma [Time frame: Predose and up to 15 days postdose]
- Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma [Time frame: Predose and up to 15 days postdose]
- Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma [Time frame: Predose and up to 15 days postdose]
- Part A: Fraction of ALN-2232 excreted in urine [Time frame: Predose and up to 8 days postdose (fe)]
- Part A: Percent Change from Baseline in Body Weight [Time frame: Baseline up to Month 12]
- Part B and Part C: Concentrations of ALN-2232 in Plasma [Time frame: Predose and up to 6 months postdose]
- Part B and Part C: Percent Change from Baseline in Body Weight [Time frame: Baseline up to Month 12]
- Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass [Time frame: Baseline up to Month 12]
Eligibility criteria
Inclusion criteria
All Parts:
- Has a body mass index (BMI) of ≥30 kg/m\^2 and <40 kg/m\^2
- Has a hemoglobin A1c (HbA1c) <6.5%
Exclusion criteria
All Parts:
- 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
Note: other protocol defined inclusion/exclusion criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Clinical Trial Site — Mount Royal
Identifiers
NCT: NCT07463846 · ALN-2232-001