Actively Recruiting
Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-12-12
60
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets. A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender. The study duration for each subject in this study is approximately 26 weeks: including a screening period of up to 4 weeks (W-28 to D-1), single-drug administration and dose escalation stages of 16 weeks (W1D1 to W16D7) and the combined drug administration stage of 6 weeks (W17D1 to W23D1)
CONDITIONS
Official Title
Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Obese Chinese adults aged 18 to 50 years who voluntarily sign informed consent
- Body mass index (BMI) between 26 and 35 kg/m2 at screening
- Able to receive subcutaneous injections and understand study procedures and potential adverse reactions
- No clinically significant abnormalities in physical exam, vital signs, lab tests, ECG, ultrasonography, chest imaging
- Females of childbearing potential must not be lactating, have negative pregnancy tests, no birth plans during study plus 8 weeks, and agree to effective contraception
- Males and females must not plan sperm or ovum donation during study plus 8 weeks
You will not qualify if you...
- History or current heart, liver, kidney, gastrointestinal, respiratory, nervous system, psychiatric, endocrine diseases (except obesity), or malignant tumors
- History of hypoglycemia, pancreatitis, pancreatic injury, symptomatic gallbladder disease, cholelithiasis with risk of pancreatitis, or newly diagnosed cholecystitis
- Significant digestive system diseases like active peptic ulcer, inflammatory bowel disease, abnormal gastric emptying, or recent hemorrhoidal attacks
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Use of drugs altering metabolizing enzymes or transporters within 4 weeks before screening
- Severe or unexplained infections within 4 weeks before screening
- Major surgery within 6 months before screening or planned surgery/hospitalization during study
- Allergies to study drug ingredients or history of severe allergies like asthma or eczema (except mild seasonal allergy)
- Use of any prescription, over-the-counter, or herbal medicines within 2 weeks before screening
- Use of GLP-1 receptor agonists or similar drugs within 6 months before screening
- Use of weight loss drugs within 6 months before screening
- Vaccination within 1 month before screening or planned vaccination during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Study site 01
Beijing, China
Actively Recruiting
Research Team
Y
yue Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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