A Phase 1 interventional study of GZR4 injection in Type 2 Diabetes, sponsored by Gan and Lee Pharmaceuticals, USA. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Gan and Lee Pharmaceuticals, USA · Phase 1, Interventional, and Treatment
In this study, the investigational product will be compared with insulin degludec (Tresiba®) and insulin icodec (Awiqli®). The comparator products are approved for the treatment of T2DM in the European Union.
This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR4 (hereafter referred to as GZR4) and estimate its potency in comparison with insulin degludec.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 14 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Gan and Lee Pharmaceuticals, USA is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed and dated obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the participant. 2. Male or female person with type 2 diabetes mellitus. 3. Age between 18 and 70 years, both inclusive. 4. (BMI) between 27.0 and 38.0 kg/m\^2, both inclusive. 5. Diabetes duration of at least 12 months. 6. Stable basal insulin regimen for at least 3 months. 7. Total daily basal insulin dose between 0.2-0.7 (I)U/kg/day, both inclusive. 8. \<= 9.0%. 9. Have venous access sufficient to allow cannulation for blood sampling as required by the protocol.
Exclusion Criteria:
Known or suspected to IMPs or any of the or to any component of the IMP formulations. 2. Previous participation in this trial. Participation is defined as randomized at Visit 2.
3. Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial. 4. Use of insulin icodec as basal insulin. 5. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction. 6. Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the investigator during the last 5 years prior to screening. 7. comorbidity, capable of constituting a risk for the participant when participating in the trial or of interfering with the interpretation of data. Signs of acute illness as judged by the investigator. 9. Any serious systemic infectious disease during four weeks before randomization in this trial, as judged by the investigator. 10. Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis as judged by the investigator. 11. Estimated (eGFR) \< 60.0 mL/min/1.73m2. 12. Systolic blood pressure \< 90 mmHg or >159 mmHg and/or diastolic blood pressure \< 50 mmHg or > 99 mmHg at screening (one repeat test will be acceptable in case of suspected white-coat hypertension). 13. Heart rate at rest (as measured in vital sign assessment at screening) outside the range of 50-90 beats per minute at screening. This exclusion criterion also applies to participants who are on anti-hypertensives. 14. Clinically significant abnormal standard 12-lead (ECG) after 5 minutes resting in a supine position at screening, as judged by the investigator. 15. Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1.5 years) ophthalmologic examination. 16. Severe neuropathy, in particular autonomic neuropathy, as judged by the investigator.
17. Recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening). 18. Hypoglycemic unawareness as judged by the investigator. 19. Hospitalization for diabetic ketoacidosis during the previous 6 months. 20. Use of oral antidiabetic drugs (OADs) within 1 month or 5 half-times (whichever is longer) prior to screening with the exception of stable doses (for at least 3 months prior to screening) of metformin, DPP4, SGLT2 inhibitors and GLP-1 receptor agonists. 21. Increased risk of thrombosis, e.g. participants with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator. 22. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24.0 grams alcohol/day (for males), 12.0 grams alcohol/day (for females) on average. 23. A positive result in the alcohol and/or urine drug screen at the screening visit.
24. Smoking more than 5 cigarettes or the equivalent per day. 25. Inability or unwillingness to refrain from smoking and use of nicotine substitute products during the inpatient period Tested positive for hepatitis Bs antigen. 27. Tested positive for antibodies. (Presence of hepatitis C antibodies will not lead to exclusion if liver function tests are normal, and a hepatitis C polymerase chain reaction is negative). 28. Positive result to the test for -1/2 antibodies or HIV-1 antigen. 29. Current treatment with systemically effective , monoamine oxidase inhibitors, systemic non-selective beta-blockers, growth hormone, non-routine vitamins or herbal products. 30. Use of non-prescription medication, including herbal products and non-routine vitamins, within 2 weeks prior screening that will interfere with PK of GZR4, insulin degludec or insulin icodec, as judged by the investigator. 31. Blood donation or blood loss of more than 500 mL within the last 3 months before screening.
32. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation. 33. Committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 34. If female, pregnancy or breast-feeding. 35. Women of who are not using a highly effective method.
36. Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method during trial participation. 37. The investigator considers a person as unsuitable for inclusion in the trial for any other reason.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each participant will undergo 3 treatment periods in a fixed-sequence design. In treatment Period 1, participants will receive insulin degludec once-daily for 7 days. In treatment Period 2, participants will receive GZR4, in treatment Period 3, participants will receive insulin icodec. Both GZR4 insulin and insulin icodec will be given once weekly over 6 weeks during two treatment periods.
Drug: GZR4 injection
GZR4 is a new ultra-long-acting insulin analog
Also known as: Degludec, Icodec
To investigate the PD of GZR4 compared to insulin degludec at steady state
AUCGIR.0-24h.ss, area under the glucose infusion rate curve over one dosing interval from 0 to 24 hours at steady state for insulin degludec AUCGIR.0-168h.ss, area under the glucose infusion rate curve over one dosing interval from 0 to 168 hours at steady state for GZR4
Time frame: 0 - 24 hours for Degulec 0-168 hours for GZR4
Started Aug 2025 (actual). Primary completion is estimated for Apr 2026, 7 months after the start.
Of 452 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's planned 7 months is above that.
Counting every sponsor, half of 514 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Insulin degludec
Gan and Lee Pharmaceuticals, USA →