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Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
A Study to Evaluate the Effect of GZR18 Injection on Gastric Emptying and Its Drug-Drug Interactions With Digoxin, Rosuvastatin Calcium and Warfarin Sodium in Obese or Overweight Subjects
Lead sponsor
Asset
GZR18
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
60
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI 26-35
Primary endpoints
•Cmax•AUC at 0 h to last observation time-point after a single dose•AUC at 0 h to infinity after a single dose
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
2. Male or female, 18 to 50 years of age at signing the ICF (both inclusive).
3. Body mass index (BMI) within 26-35 kg/m2 (both ends inclusive) at screening.
4. No abnormality or not clinically significant abnormality as judged by the investigator in physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, urinalysis, thyroid function and coagulation), 12-lead ECG, ultrasonography of liver, gallbladder, pancreas, and spleen + both kidneys, chest imaging examination and other results. (abnormal indicators related to obesity or overweight, and the investigator assesses that they have no impact on this study, they can be enrolled)
5. Subjects of childbearing potential with no birth plan from the signing of the ICF to 8 weeks 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 for blood pregnancy test at screening (including D-1).
Exclusion criteria
2. History or existing diseases that increase the risk of subjects, such as hypoglycemia, 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 or bile duct stone ≤ 5 mm in diameter),newly diagnosed cholecystitis at screening.
3. Subjects with previous or existing clinically significant digestive system diseases who are judged unsuitable for the study by the investigator, such as history of active peptic ulcer or hemorrhage, inflammatory bowel disease, abnormal gastric emptying (such as gastric paresis or pyloric stenosis, gastric outlet obstruction), continuous use of drugs affecting gastrointestinal motility for ≥ 1 week (including but not limited to domperidone, mosapride, macrolides), and acute hemorrhoidal attacks within the past three months.
4. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.
5. Subjects who have used any drugs that alter the activity of drug metabolizing enzymes or transporters within 4 weeks prior to screening, or subjects with acute diseases or concomitant medication from the screening period to before administration of the investigational medicinal product (IMP).
6. Subjects with severe infection or unexplained infection within 4 weeks before screening.
7. Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.
8. Subjects with allergic constitution prior to screening, or a history of bronchial asthma, eczema and other allergic diseases (except mild seasonal allergy), or a history of severe food allergy (such as laryngeal edema, shock), or known allergy to any ingredient in investigational medicinal products (IMPs) [GLP-1 receptor (GLP-1R) agonist, paracetamol, digoxin, rosuvastatin, warfarin and their excipients].
9. Use of any prescription drugs, over-the-counter drugs or Chinese herbal medicines within 2 weeks prior to screening; or use of any GLP-1R agonists or drugs with the same mechanism of action to GLP-1R agonists [such as GLP-1R/glucagon receptor (GCGR) agonists or gastric inhibitory polypeptide receptor (GIPR)/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists] within 6 months prior to screening; or use of any weight loss drugs within 6 months prior to screening.
10. Subjects who have been vaccinated within 1 month before screening or are scheduled for vaccination during the study.
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
Safety / tolerability / PK
7 endpointsCmax:Maximum plasma concentration
Time frame:through study completion,up to 16 weeks
concentration, descriptive
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Time frame:through study completion,up to 16 weeks
concentration, descriptive
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Time frame:through study completion,up to 16 weeks
concentration, descriptive
Tmax:Time of Maximum Drug Concentration
Time frame:through study completion,up to 16 weeks
concentration, descriptive
t1/2: Elimination half-life
Time frame:through study completion,up to 16 weeks
concentration, descriptive
CL/F: Apparent clearance rate
Time frame:through study completion,up to 16 weeks
concentration, descriptive
Vz/F:Apparent Volume of Distribution associated with the Terminal Phase following Oral Administration
Time frame:through study completion,up to 16 weeks
ratio, event
Other (unclassified)
1 endpointPD:Area under the international normalized ratio-time curve (INRAUC) and maximum international normalized ratio postdose (INRMAX) for warfarin
Time frame:through study completion,up to 16 weeks
ratio, improvement
Provenance
Sources
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 1, 2026 snapshot.