Obesity
Conditions
Keywords
siRNA, RNAi therepeutic
Brief summary
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
DRUGALN-2232
ALN-2232 will be administered subcutaneously (SC)
DRUGPlacebo
Placebo will be administered SC
DRUGTirzepatide
Tirzepatide will be administered SC
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Frequency of Adverse Events (AEs) | Up to 12 months |
| Part B: Percent Change from Baseline in Body Weight | Baseline up to Month 6 |
| Part C: Percent Change from Baseline in Body Weight | Baseline up to Month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Change from Baseline in Proteins in Adipose Tissue | Baseline up to Month 12 | — |
| Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma | Predose and up to 15 days postdose | — |
| Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma | Predose and up to 15 days postdose | — |
| Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma | Predose and up to 15 days postdose | — |
| Part A: Fraction of ALN-2232 excreted in urine | Predose and up to 8 days postdose (fe) | — |
| Part A: Percent Change from Baseline in Body Weight | Baseline up to Month 12 | — |
| Part B and Part C: Concentrations of ALN-2232 in Plasma | Predose and up to 6 months postdose | — |
| Part B and Part C: Percent Change from Baseline in Body Weight | Baseline up to Month 12 | — |
| Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass | Baseline up to Month 12 | Measured by dual x-ray absorptiometry (DXA) |
Countries
Canada
Contacts
CONTACTAlnylam Clinical Trial Information Line
STUDY_DIRECTORMedical Director
Alnylam Pharmaceuticals
Outcome results
None listed