Bioequivalence Study of GZR18 Injection Before and After CMC Change

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

Bioequivalence Study of GZR18 Injection Before and After CMC Change (NCT07355738) is a Phase 1 interventional studying Obesity&T2D, sponsored by Gan & Lee Pharmaceuticals.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Obesity&T2D, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 138 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Obesity&T2D subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects who voluntarily sign the willing to sign a consent form 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, 18 to 50 years of age at signing the ICF (both inclusive). 3. Weight ≥ 50 kg and body mass index (BMI) within 19-26 kg/m2 (inclusive) at screening. 4. 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 Should NOT Join This Trial: 1. 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. 2. Subjects who test positive for hepatitis B virus surface antigen, hepatitis C virus IgG antibody, human weakened immune system virus antibody, P24 antigen, or anti-treponema pallidum antibody. 3. 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. 4. History of acute or chronic pancreatitis and pancreatic injury before screening. 5. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2. 6. 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. 7. Subjects with severe infection or unexplained infection within 4 weeks before screening. 8. Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. 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, 18 to 50 years of age at signing the ICF (both inclusive). 3. Weight ≥ 50 kg and body mass index (BMI) within 19-26 kg/m2 (inclusive) at screening. 4. 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. \- Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. History of acute or chronic pancreatitis and pancreatic injury before screening. 5. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2. 6. 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. 7. Subjects with severe infection or unexplained infection within 4 weeks before screening. 8. Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study. 9. 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). 10. 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. 11. Subjects who have been vaccinated within 1 month before screening or are scheduled for vaccination during the study. 12. 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. 13. History of drug abuse prior to screening; or positive results for drug abuse at screening (D-1). 14. 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). 15. 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. 16. 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. 17. 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. 18. Subjects who have special dietary requirements and cannot adhere to a standardized diet, or who are lactose intolerant. 19. Subjects with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venous blood collection. 20. Subjects who are investigators or employees of the study site, or family members of the employees or investigators. 21. 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. \-

Treatments Being Tested

DRUG

GZR18 injection A

Administered SC

DRUG

GZR18 injection B

Single dose, s.c.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Second Affiliated Hospital of Soochow University

Suzhou, Suzhou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07355738), the sponsor (Gan & Lee Pharmaceuticals.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07355738 clinical trial studying?

Who can participate in NCT07355738?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07355738?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07355738. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07355738. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.