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New treatment option for Obesity&T2D
Official title Bioequivalence Study of GZR18 Injection Before and After CMC Change
ClinicalTrials.gov ID: NCT07355738
What this study is testing
What is GZR18 injection A?
GZR18 injection A is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity&t2d.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, men only. Healthy volunteers may be eligible.
You may be able to join if
- people who voluntarily sign the Informed Consent Form (ICF), can receive SC injection, fully understand the content, process and possible adverse...
- 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.
- people of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective...
You likely can't join if
- people with clinically significant abnormalities detected during the screening period in physical examination, vital signs, laboratory tests, 12-lead...
- people who test positive for hepatitis B virus surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody, P24 antigen...
- people with a history of or existing circulatory, urinary, digestive, respiratory, nervous, endocrine, or psychiatric disorders that, in the...
- 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.
- people who have used any drugs that alter the activity of drug metabolizing enzymes or transporters within 4 weeks prior to screening, or people with...
See the full eligibility criteria
- people 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...
- 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.
- people 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. \-
- people 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...
- people 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.
- people 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.
- people who have used any drugs that alter the activity of drug metabolizing enzymes or transporters within 4 weeks prior to screening, or people with acute diseases or concomitant medication from the screening period to...
- people 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.
- people 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...
- people 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...
- people 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.
- people 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.
- people 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.
- people who have special dietary requirements and cannot adhere to a standardized diet, or who are lactose intolerant.
- people with a history of needle phobia and blood phobia, difficulty in blood collection or intolerance to venous blood collection.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Suzhou, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Suzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.