A Study to Evaluate ALN-6222 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-6222, Placebo.
- 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, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ALN-6222 in Adult Participants With Obesity
Overview
This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants with obesity.
Interventions
- Drug ALN-6222
ALN-6222 will be administered subcutaneously (SC). - Drug Placebo
Placebo will be administered SC.
Primary outcome measures
- Frequency of Adverse Events [Time frame: Up to 12 months]
Secondary outcome measures (2)
- Concentrations of ALN-6222 in Plasma [Time frame: Predose and up to 3 days postdose]
- Change from Baseline Protein Markers in Plasma [Time frame: Predose and up to 12 months postdose]
Eligibility criteria
Inclusion Criteria -
- Is an adult patient with a body mass index ≥30 kg/m\^2 to <40 kg/m\^2
- Has a hemoglobin A1c <6.5%
Exclusion Criteria -
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)
- Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- Has an estimated glomerular filtration (eGFR) of <60 mL/min/1.73m\^2 at screening
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: NCT07624071 · ALN-6222-001