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RecruitingPhase 1

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

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

CmaxAUC at 0 h to last observation time-point after a single doseAUC 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

NCT IDNCT07128888
Org study IDGZR18-BWM-104

Timeline

Milestones

Study first posted2025-08-19actual
Study start2025-11-17actual
Last update posted2025-12-12actual
Primary completion2026-07-05estimated
Study completion2026-07-05estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1.Obese Chinese subjects, who voluntarily sign the Informed Consent Form (ICF), can receive SC 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.

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

1.Subjects with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disorders, endocrine diseases (except obesity), malignant tumors and other diseases that are judged by the investigator to have an impact on the evaluation of the results of this study.

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
Other (unclassified)
1

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

Cmax:Maximum plasma concentration

Time frame:through study completion,up to 16 weeks

concentration, descriptive

Primary/protocol endpoint

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

Primary/protocol endpoint

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

Secondary/protocol endpoint

Tmax:Time of Maximum Drug Concentration

Time frame:through study completion,up to 16 weeks

concentration, descriptive

Secondary/protocol endpoint

t1/2: Elimination half-life

Time frame:through study completion,up to 16 weeks

concentration, descriptive

Secondary/protocol endpoint

CL/F: Apparent clearance rate

Time frame:through study completion,up to 16 weeks

concentration, descriptive

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint/low confidence

PD: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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.