Obesity or OverweightPhase 1NCT07128888
Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
A Phase 1 study testing GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets in people with Obesity or Overweight, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity or Overweight
- What is being tested?
- GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2025to 5 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Obesity or Overweight
- Being tested
- GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tabletsDrug
GZR18 injection: 3 mg-36 mg，16 weeks; Warfarin Sodium Tablets:2.5mg，twice; Rosuvastatin Calcium Tablets：10mg，twice; Digoxin Tablets:0.25mg，twice
| Study group | Role | What they receive |
|---|---|---|
| GZR18 injection | Experimental | Not described Receives: Drug: GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax:Maximum plasma concentration
Measured: through study completion,up to 16 weeks
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Measured: through study completion,up to 16 weeks
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Measured: through study completion,up to 16 weeks
Secondary outcomes (5)
Tmax:Time of Maximum Drug Concentration
Measured: through study completion,up to 16 weeks
t1/2: Elimination half-life
Measured: through study completion,up to 16 weeks
CL/F: Apparent clearance rate
Measured: through study completion,up to 16 weeks
Vz/F:Apparent Volume of Distribution associated with the Terminal Phase following Oral Administration
Measured: through study completion,up to 16 weeks
PD:Area under the international normalized ratio-time curve (INRAUC) and maximum international normalized ratio postdose (INRMAX) for warfarin
Measured: through study completion,up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start17 Nov 2025
- Primary completion5 Jul 2026 (estimated)
- Study completion5 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity or OverweightStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128888
- Sponsor's protocol ID
- GZR18-BWM-104
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07128888
- Acronym / sponsor ID
- GZR18-BWM-104
- Conditions
- Obesity or Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 5 Jul 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GZR18 injection | Experimental | Drug: GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tabletsGZR18 injection: 3 mg-36 mg，16 weeks; Warfarin Sodium Tablets:2.5mg，twice; Rosuvastatin Calcium Tablets：10mg，twice; Digoxin Tablets:0.25mg，twice | Drug | GZR18 injection |
Primary outcome
Cmax:Maximum plasma concentration
Time frame: through study completion,up to 16 weeks
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
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
5 secondary outcomes
Tmax:Time of Maximum Drug Concentration
Time frame: through study completion,up to 16 weeks
t1/2: Elimination half-life
Time frame: through study completion,up to 16 weeks
CL/F: Apparent clearance rate
Time frame: through study completion,up to 16 weeks
Vz/F:Apparent Volume of Distribution associated with the Terminal Phase following Oral Administration
Time frame: through study completion,up to 16 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets in people with Obesity or Overweight, run by Gan & Lee Pharmaceuticals. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yue Liu (010-56456739, yue3.liu@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax:Maximum plasma concentration (time frame: through study completion,up to 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.