Not yet recruitingPhase 1

A Phase I Clinical Study to Evaluate the Effect of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochloride Tablets in Overweight/Obese Subjects

A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Repeated Subcutaneous Injections of GZR18 Injection on the Pharmacokinetics of Oral Metformin Hydrochloride Tablets in Overweight/Obese Subjects

Lead sponsor

Gan and Lee Pharmaceuticals, USA

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•BMI 24-33

Primary endpoints

•Cmax,ss•AUC0-tau

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06670209

Org study IDGZR18-T2D-103

Timeline

Milestones

Study start2024-10-30estimated

Study first posted2024-11-01actual

Last update posted2024-11-01actual

Primary completion2025-03-19estimated

Study completion2025-03-19estimated

Assets

Investigational agents

GZR18

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Overweight/obese Chinese subjects, who voluntarily sign the Informed Consent Form (ICF), can receive subcutaneous injection, fully understand the content, process and possible adverse reactions of the trial, and are able to follow the regulations on contraindications and restrictions specified in this protocol.

•Male or female, 18 to 50 years of age at signing the ICF (both inclusive).

•Weight ≥ 50 kg and body mass index (BMI) within 24-33 kg/m2 (both ends inclusive) at screening.

•Subjects of childbearing potential with no birth plan from the signing of ICF to 3 months after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (prior to enrollment).

Exclusion criteria

•Subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disease, malignant tumor and other diseases that are judged by the investigator to have an impact on pharmacokinetics and safety evaluation.

•History or existing diseases that increase the risk of subjects, such as hypoglycaemia, acute or chronic pancreatitis, pancreatic injury, history of symptomatic gallbladder disease; cholelithiasis with high risk of acute biliary pancreatitis at screening (e.g., silt-like lithiasis, gallbladder ≤ 5 mm in diameter and bile duct stone, etc.).

•Subjects with previous or existing diseases that significantly affect drug absorption, metabolism or excretion, such as history of active peptic ulcer or haemorrhage, inflammatory bowel disease, abnormal gastric emptying (such as gastric paresis or pyloric stenosis, gastric outlet obstruction), long-term use (continuous for ≥ 1 week) of drugs that affect gastrointestinal motility (including but not limited to domperidone, mosapride, macrolides).

•Subjects with severe infection or unexplained infection within 4 weeks before screening.

•Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.

•History of drug abuse prior to screening; or positive results for drug abuse at screening.

•Subjects who used nicotine-containing products within 3 months prior to screening or are screened positive for nicotine in urine.

•Other factors that make subjects unqualified to participate in this trial as judged by the Investigator.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Cmax,ss

Time frame:24 hours

concentration, descriptive

Primary/protocol endpoint

AUC0-tau

Time frame:24 hours

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.