Actively Recruiting
Study Evaluating GZR18 Injection Effects on Gastric Emptying and Drug Interactions with Digoxin, Rosuvastatin Calcium, and Warfarin Sodium in Obese or Overweight Adults
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-12-12
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of GZR18 Injection on gastric emptying and its interactions with oral drugs digoxin, rosuvastatin calcium, and warfarin sodium in obese or overweight adults. This is a phase I, single-center, open-label study involving 60 participants with an equal gender distribution, aged 18 to 50 years, focusing on how repeated subcutaneous injections of GZR18 influence these oral medications' behavior in the body. Participants receive GZR18 injections ranging from 3 mg to 36 mg over 16 weeks, alongside oral administration of warfarin sodium tablets (2.5 mg twice daily), rosuvastatin calcium tablets (10 mg twice daily), and digoxin tablets (0.25 mg twice daily). The study includes a 4-week screening period, followed by 16 weeks of single-drug administration and dose escalation, and concludes with a 6-week combined drug administration phase. Throughout the approximately 26-week participation, subjects undergo physical exams, vital signs monitoring, lab tests including blood chemistry and coagulation, ECGs, and imaging of internal organs. Researchers measure drug concentration levels in the blood and other pharmacokinetic parameters up to 16 weeks. Safety and drug interaction effects are closely monitored during and after treatment.
CONDITIONS
Brief 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 who voluntarily sign informed consent and can receive subcutaneous injections.
- Male or female aged 18 to 50 years at consent.
- Body mass index (BMI) between 26 and 35 kg/m2 at screening.
- No clinically significant abnormalities in physical exams, vital signs, labs, ECG, and imaging as judged by investigators.
- Females of childbearing potential must not be lactating, have a negative pregnancy test at screening, use effective contraception, and have no plans for pregnancy or sperm/ovum donation during the study and 8 weeks after last dose.
You will not qualify if you...
- History or existing heart, liver, kidney, gastrointestinal, respiratory, nervous system, psychiatric, endocrine diseases (except obesity), malignancies, or other diseases impacting study results.
- History of hypoglycemia, pancreatitis, pancreatic injury, symptomatic gallbladder disease, cholelithiasis with high risk for pancreatitis, or cholecystitis.
- Clinically significant digestive 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 drug metabolism enzymes or transporters within 4 weeks before screening.
- Severe or unexplained infection within 4 weeks before screening.
- Major surgery within 6 months before screening or planned surgery/hospitalization during study.
- Allergic conditions including asthma, eczema, severe food allergies, or known allergy to study drug ingredients.
- Use of prescription, over-the-counter, or herbal medicines within 2 weeks before screening; use of GLP-1 receptor agonists or weight loss drugs within 6 months.
- Vaccination within 1 month before screening or planned during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive GZR18 injection and other study drugs to evaluate their effects on gastric emptying and drug interactions.
Multiple visits during the 16 weeks
Trial Site Locations
Total: 1 location
1
Study site 01
Beijing, China
Actively Recruiting
Research Team
Y
yue Liu
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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