Obesity&T2DPhase 1NCT07355738
Bioequivalence Study of GZR18 Injection Before and After CMC Change
A Phase 1 study testing GZR18 injection A and GZR18 injection B in people with Obesity&T2D, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects. The study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity&T2D
- What is being tested?
- GZR18 injection A and GZR18 injection B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2026to 20 May 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Male, 18 to 50 years of age at signing the ICF (both inclusive).
- Weight ≥ 50 kg and body mass index (BMI) within 19-26 kg/m2 (inclusive) at screening.
- Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation.
- -
Who cannot join
- Subjects with clinically significant abnormalities detected during the screening period in physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray, as determined by the investigator.
- Subjects who test positive for hepatitis B virus surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody, P24 antigen, or anti-treponema pallidum antibody.
- Subjects with a history of or existing circulatory, urinary, digestive, respiratory, nervous, endocrine, or psychiatric disorders that, in the investigator's judgment, remain clinically significant.
- History of acute or chronic pancreatitis and pancreatic injury before screening.
- History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.
- 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 randomization.
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- Subjects with severe infection or unexplained infection within 4 weeks before screening.
- Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.
- Subjects known or suspected to have hypersensitivity to any ingredient of the investigational medicinal product (IMP) (glucagon like peptide-1 receptor agonist (GLP-1RA) or its excipients).
- Use of any prescription drugs, over-the-counter drugs or Chinese herbal medicine within 2 weeks prior to screening; 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 3 months prior to screening.
- Subjects who have been vaccinated within 1 month before screening or are scheduled for vaccination during the study.
- Blood donation or blood loss greater than or equal to 400 mL within 3 months before screening, or blood donation scheduled during the study or within 8 weeks after the end of the study.
- History of drug abuse prior to screening; or positive results for drug abuse at screening (D-1).
- History of alcohol abuse within 3 months prior to screening, defined as an average intake of more than 14 units per week (1 standard unit=360 mL of beer or 150 mL of 12% wine or 45 mL of 40% spirits); or use of any alcohol-containing products 48 hours before administration; or abnormal results for breath alcohol test at screening (D-1).
- Subjects who smoked more than 5 cigarettes per day on average within the 3 months before screening, or who do not agree to abstain from smoking for the duration of the study.
- Subjects who engage in strenuous exercise within 48 h before administration of the IMP, or have other factors that may affect drug absorption, distribution, metabolism, or excretion.
- Subjects who consume grapefruit or grapefruit-containing products, or any caffeinated or xanthine-containing foods or beverages (such as coffee, tea, cola, or chocolate) within 48 hours before administration of the IMP.
- Subjects who have special dietary requirements and cannot adhere to a standardized diet, or who are lactose intolerant.
- Subjects with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venous blood collection.
- Subjects who are investigators or employees of the study site, or family members of the employees or investigators.
- Participation in a clinical study of another IMP or device within 3 months before screening, or within 5 half-lives of the previous IMP (whichever is longer). Or plan to participate in another clinical study of an IMP or device before completing all scheduled assessments in the clinical study.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Suzhou
Xin Zhang Xin Zhang, 010-56456739, xin5.zhang@ganlee.com
About this study
Official title: A Randomized, Open-label, Single-dose, Parallel Comparison Study to Evaluate the Bioequivalence of GZR18 Injection Before and After CMC Change in Healthy Adult Male Subjects
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
The study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes.
Read more
Subjects eligible for each part of the screening will be randomized into Group A or Group B in a 1:1 ratio. Each subject will receive a single dose of GZR18 Injection, followed by PK blood sampling and safety follow-up for 35 days. Subjects will be admitted to the hospital 1 day predose, follow a standardized light diet that evening, and then fast for at least 10 h thereafter. On the day of administration, GZR18 Injection of a single strength will be administered subcutaneously under fasting conditions at a site approximately two finger-widths (2.5 cm) away from the umbilicus on the abdomen. Lunch and dinner will be served approximately 3 and 9 h postdose, respectively.
Venous blood will be collected at 14 time points for GZR18 plasma concentration analysis: at 0 h (within 60 min predose) and 1, 6, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, and 840 h postdose.
Subjects will undergo corresponding laboratory safety tests at screening, D36, and early withdrawal visits.
During the entire study period, subjects should maintain a light diet, avoid strenuous exercise, and refrain from consuming juice, caffeinated beverages (such as tea and coffee), and alcoholic drinks. Smoking and any other activities that may affect PK observation or safety evaluations are strictly prohibited.
- Conditions
- Obesity&T2D
- Being tested
- GZR18 injection A, GZR18 injection B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR18 injection ADrug
Administered SC
GZR18 injection BDrug
Single dose, s.c.
| Study group | Role | What they receive |
|---|---|---|
| GZR18 injection A1 | Experimental | Single dose, s.c. Receives: Drug: GZR18 injection A |
| GZR18 injection B1 | Experimental | Single dose, s.c. Receives: Drug: GZR18 injection B |
| GZR18 injection A2 | Experimental | Not described Receives: Drug: GZR18 injection A |
| GZR18 injection B2 | Experimental | Not described Receives: Drug: GZR18 injection B |
| GZR18 injection A3 | Experimental | Not described Receives: Drug: GZR18 injection A |
| GZR18 injection B3 | Experimental | Not described Receives: Drug: GZR18 injection B |
What is being measured
The primary outcome is the main question the study is designed to answer.
the maximum concentration (Cmax)
Measured: Day1-Day36
the area under the concentration-time curve during a dosing interval (AUC0-t)
Measured: Day1-Day36
the area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0-∞)
Measured: Day1-Day36
Secondary outcomes (5)
AUC extrapolated from the last time point extrapolated to infinity in percentage of the AUC0-∞ (AUC_%Extra)
Measured: Day1-Day36
time of maximum observed concentration (Tmax)
Measured: Day1-Day36
elimination half-life (t1/2)
Measured: Day1-Day36
elimination rate constant of plasma concentration at terminal phase (λz)
Measured: Day1-Day36
Treatment-Emergent Adverse Events (TEAEs)
Measured: Day1-Day36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start9 Jan 2026
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity&T2DStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 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
- NCT07355738
- Sponsor's protocol ID
- GZR18-OOO-108
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Parallel Comparison Study to Evaluate the Bioequivalence of GZR18 Injection Before and After CMC Change in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT07355738
- Acronym / sponsor ID
- GZR18-OOO-108
- Conditions
- Obesity&T2D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 21 Jan 2026 (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 an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
The study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes.
Subjects eligible for each part of the screening will be randomized into Group A or Group B in a 1:1 ratio. Each subject will receive a single dose of GZR18 Injection, followed by PK blood sampling and safety follow-up for 35 days. Subjects will be admitted to the hospital 1 day predose, follow a standardized light diet that evening, and then fast for at least 10 h thereafter. On the day of administration, GZR18 Injection of a single strength will be administered subcutaneously under fasting conditions at a site approximately two finger-widths (2.5 cm) away from the umbilicus on the abdomen. Lunch and dinner will be served approximately 3 and 9 h postdose, respectively.
Venous blood will be collected at 14 time points for GZR18 plasma concentration analysis: at 0 h (within 60 min predose) and 1, 6, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, and 840 h postdose.
Subjects will undergo corresponding laboratory safety tests at screening, D36, and early withdrawal visits.
During the entire study period, subjects should maintain a light diet, avoid strenuous exercise, and refrain from consuming juice, caffeinated beverages (such as tea and coffee), and alcoholic drinks. Smoking and any other activities that may affect PK observation or safety evaluations are strictly prohibited.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GZR18 injection A1 | Experimental | Drug: GZR18 injection ASingle dose, s.c. |
| GZR18 injection B1 | Experimental | Drug: GZR18 injection BSingle dose, s.c. |
| GZR18 injection A2 | Experimental | Drug: GZR18 injection A |
| GZR18 injection B2 | Experimental | Drug: GZR18 injection B |
| GZR18 injection A3 | Experimental | Drug: GZR18 injection A |
| GZR18 injection B3 | Experimental | Drug: GZR18 injection B |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Male, 18 to 50 years of age at signing the ICF (both inclusive).
- Weight ≥ 50 kg and body mass index (BMI) within 19-26 kg/m2 (inclusive) at screening.
- Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation.
- -
Key exclusion criteria (22 listed)
- Subjects with clinically significant abnormalities detected during the screening period in physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray, as determined by the investigator.
- Subjects who test positive for hepatitis B virus surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody, P24 antigen, or anti-treponema pallidum antibody.
- Subjects with a history of or existing circulatory, urinary, digestive, respiratory, nervous, endocrine, or psychiatric disorders that, in the investigator's judgment, remain clinically significant.
- History of acute or chronic pancreatitis and pancreatic injury before screening.
- History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.
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 AAdministered SC | Drug | GZR18 injection A1, GZR18 injection A2, GZR18 injection A3 |
| GZR18 injection BSingle dose, s.c. | Drug | GZR18 injection B1, GZR18 injection B2, GZR18 injection B3 |
Primary outcome
the maximum concentration (Cmax)
Time frame: Day1-Day36
the area under the concentration-time curve during a dosing interval (AUC0-t)
Time frame: Day1-Day36
the area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0-∞)
Time frame: Day1-Day36
5 secondary outcomes
AUC extrapolated from the last time point extrapolated to infinity in percentage of the AUC0-∞ (AUC_%Extra)
Time frame: Day1-Day36
time of maximum observed concentration (Tmax)
Time frame: Day1-Day36
elimination half-life (t1/2)
Time frame: Day1-Day36
elimination rate constant of plasma concentration at terminal phase (λz)
Time frame: Day1-Day36
Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day1-Day36
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 22 Jan 2026.
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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 A and GZR18 injection B in people with Obesity&T2D, 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 22 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 22 Jan 2026. 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 Xin Zhang Xin Zhang (010-56456739, xin5.zhang@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the maximum concentration (Cmax) (time frame: Day1-Day36). 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 22 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.