A Study to Evaluate ALN-6222 in Participants With Obesity

Alnylam Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo; Drug: ALN-6222

Study type: Interventional

Funder types: Industry

Identifiers

NCT07624071

ALN-6222-001

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

ALN-6222

Experimental group

Description:

Participants will be administered a single dose of ALN-6222.

Treatment:

Drug: ALN-6222

Placebo

Placebo Comparator group

Description:

Participants will be administered a single dose of placebo.

Treatment:

Drug: Placebo