GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 3

A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects

Lead sponsor

Gan & Lee Pharmaceuticals.

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

630

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Weight from baseline (%)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06728124

Org study IDGZR18-BWM-301

Timeline

Milestones

Study first posted2024-12-11actual

Study start2024-12-30actual

Last update posted2025-11-25actual

Primary completion2026-05estimated (month precision)

Study completion2026-05estimated (month precision)

Assets

Investigational agents

GZR18

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.

•Obese (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI < 28 kg/m2) with at least one comorbidity.

•Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.

•Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).

Exclusion criteria

•Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.

•History of drug abuse prior to screening.

•History of alcohol abuse within 6 months before screening.

•Weight change of > 5.0% within 3 months before screening (self-report).

•Presence of limb deformity or mutilation affecting height measurement.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Other (unclassified)