Type 2 DiabetesPhase 1NCT06974487
A Phase I Study to Evaluate the PK and PD Profiles of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects
A Phase 1 study testing GZR102 injection, GZR4 injection and GZR18 injection in people with Type 2 Diabetes, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- GZR102 injection, GZR4 injection and GZR18 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2025to 30 Sep 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- 2. Subjects (male or female) age 18-60 years old (inclusive) at the time of signing ICF.
- 3. Body weight ≥ 60 kg, body mass index (BMI) ≥ 24 kg/m2 and < 28 kg/m2 at screening.
- 4. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
Who cannot join
- 1. History of drug abuse prior to screening; or positive results for drug abuse at screening.
- 2. History of alcohol abuse defined as an average alcohol 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) within 6 months prior to screening.
- 3. Subjects who smoked > 5 cigarettes/day within 3 months prior to screening or who cannot stop using any tobacco products during the study.
- 4. Subjects with a history of allergy to ≥ 2 drugs, or known hypersensitivity or intolerance to the IMP or similar products and their excipients.
- 5. Presence of any suspected and/or definitively diagnosed malignancy at screening; or patients diagnosed with other malignancies within 5 years; 6. Previous or current medical history of cardiovascular, hematological, respiratory, digestive, urinary, endocrine/metabolic, neurological, or psychiatric disorders that, in the investigator's judgment, may affect the study outcomes.
- 7. History of acute or chronic pancreatitis, biliary/gallbladder diseases , or pancreatic injury.
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- 8. Major surgery (including but not limited to procedures requiring general anesthesia) within 3 months prior to screening; or history of organ transplantation (except corneal transplantation performed more than 4 months prior to screening); or incomplete recovery from illness, trauma, or surgery at screening (e.g., significant impairment in daily living or working capacity compared to pre-illness/injury/surgery status); or planned surgery during the study period.
- 9. Blood donation or significant blood loss (> 400 mL), or blood transfusion in the 3 months prior to screening.
- 10. Presence of any clinically significant abnormalities in 12-lead electrocardiogram, vital signs (blood pressure, respiration, pulse rate, body temperature), physical examination, imaging examination, or laboratory tests (hematology, urinalysis, blood chemistry, coagulation function, serum amylase, serum lipase, calcitonin) as determined by the investigator at screening..
- 11. Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody infection at screening.
- 12. History of organ transplantation, or acquired or congenital immune system disorders.
- 13. Participation in a clinical study of another investigational medicinal product (IMP), surgery, 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, surgery, or device before completing all scheduled assessments in the clinical study.
- 14. Subjects who have used GLP-1 receptor agonists or drugs with the mechanism of action of GLP-1R agonists.
- 15. Subjects who are allergic to any food or have specific dietary requirements and cannot adhere to a standardized diet.
- 16. History of needle or blood phobia, or difficulty with blood collection; or inability/unwillingness to undergo repeated venipuncture.
- 17. Subjects who were considered not suitable for the clinical study due to other reasons at the discretion of the investigator.
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 Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects
This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately.
Subjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.
- Conditions
- Type 2 Diabetes
- Being tested
- GZR102 injection, GZR4 injection, GZR18 injection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GZR102 injectionDrug
Participants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）.
GZR4 injectionDrug
Participants will get a single dose of GZR4 injection
GZR18 injectionDrug
Participants will get a single dose of GZR18 injection
| Study group | Role | What they receive |
|---|---|---|
| GZR102 injection | Experimental | Participants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）. Receives: Drug: GZR102 injection |
| GZR4 injection | Active comparator | Participants will get a single dose of GZR4 injection Receives: Drug: GZR18 injection |
| GZR18 injection | Active comparator | Participants will get a single dose of GZR18 injection Receives: Drug: GZR4 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
Measured: Day 36 (end of period)
Secondary outcomes (5)
AUC0-inf
Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
Measured: Day 36 (end of period)
TEAEs
Treatment-emergent adverse events in terms of number of subject
Measured: Day 36 (end of period)
Hypoglycemia
Number of subjects, number of events and incidence of treatment-emergent hypoglycemia.
Measured: Day 36 (end of period)
Immunogenicity
Including anti-drug antibody (ADA) and neutralizing antibody (NAb).
Measured: Day 36 (end of period)
Cmax
Maximum plasma concentration
Measured: Day 36 (end of period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start8 May 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT06974487
- Sponsor's protocol ID
- GZR102-T2D-101
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 16 May 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Crossover Phase I Clinical Study to Evaluate the Safety, Tolerability, PK and PD Profiles of a Single Dose of GZR102 Injection Versus GZR4 Injection and GZR18 Injection Given Separately in Chinese Adult Overweight Subjects
- ClinicalTrials.gov ID
- NCT06974487
- Acronym / sponsor ID
- GZR102-T2D-101
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 8 May 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 May 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 trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately.
Subjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GZR102 injection | Experimental | Drug: GZR102 injectionParticipants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）. |
| GZR4 injection | Active comparator | Drug: GZR18 injectionParticipants will get a single dose of GZR4 injection |
| GZR18 injection | Active comparator | Drug: GZR4 injectionParticipants will get a single dose of GZR18 injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- 2. Subjects (male or female) age 18-60 years old (inclusive) at the time of signing ICF.
- 3. Body weight ≥ 60 kg, body mass index (BMI) ≥ 24 kg/m2 and < 28 kg/m2 at screening.
- 4. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
Key exclusion criteria (16 listed)
- 1. History of drug abuse prior to screening; or positive results for drug abuse at screening.
- 2. History of alcohol abuse defined as an average alcohol 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) within 6 months prior to screening.
- 3. Subjects who smoked > 5 cigarettes/day within 3 months prior to screening or who cannot stop using any tobacco products during the study.
- 4. Subjects with a history of allergy to ≥ 2 drugs, or known hypersensitivity or intolerance to the IMP or similar products and their excipients.
- 5. Presence of any suspected and/or definitively diagnosed malignancy at screening; or patients diagnosed with other malignancies within 5 years; 6. Previous or current medical history of cardiovascular, hematological, respiratory, digestive, urinary, endocrine/metabolic, neurological, or psychiatric disorders that, in the investigator's judgment, may affect the study outcomes.
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 |
|---|---|---|
| GZR102 injectionParticipants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）. | Drug | GZR102 injection |
| GZR4 injectionParticipants will get a single dose of GZR4 injection | Drug | GZR18 injection |
| GZR18 injectionParticipants will get a single dose of GZR18 injection | Drug | GZR4 injection |
Primary outcome
AUC0-t
Time frame: Day 36 (end of period)
Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
5 secondary outcomes
AUC0-inf
Time frame: Day 36 (end of period)
TEAEs
Time frame: Day 36 (end of period)
Hypoglycemia
Time frame: Day 36 (end of period)
Immunogenicity
Time frame: Day 36 (end of period)
Cmax
Time frame: Day 36 (end of period)
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 16 May 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 GZR102 injection, GZR4 injection and GZR18 injection in people with Type 2 Diabetes, 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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 16 May 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 xuepeng Chen (010-56456739, xuepeng.chen@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: Day 36 (end of period)). 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 16 May 2025.