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New treatment option for Obesity or Overweight
Official title Study on Gastric Emptying Effect and Drug-Drug Interactions of GZR18 Injection
ClinicalTrials.gov ID: NCT07128888
What this study is testing
What is GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets?
GZR18 injection,digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for obesity or overweight.
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 a single-center, open-label, fixed-sequence phase I clinical study to evaluate the effect of GZR18 Injection on gastric emptying and the effect of repeated SC injections of GZR18 Injection on the pharmacokinetics of oral digoxin tablets, rosuvastatin calcium tablets and warfarin sodium tablets. A total of 60 obese or overweight subjects are planned to be enrolled, with no less than one-quarter of the subjects from either gender.
- Phase 1: an early, usually small safety study
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
You may be able to join if
- 1.Obese Chinese people, who voluntarily sign the Informed Consent Form (ICF), can receive SC injection, fully understand the content, process and...
- 2\. Male or female, 18 to 50 years of age at signing the ICF (both inclusive).
- 3\. Body mass index (BMI) within 26-35 kg/m2 (both ends inclusive) at screening.
- 4\. No abnormality or not clinically significant abnormality as judged by the investigator in physical examination, vital signs, routine laboratory...
- 5\. people of childbearing potential with no birth plan from the signing of the ICF to 8 weeks after the last dose, willingness to take effective...
You likely can't join if
- 1.people with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric...
- 2\. History or existing diseases that increase the risk of people, such as hypoglycemia, acute or chronic pancreatitis, pancreatic injury, history of...
- 3\. people with previous or existing clinically significant digestive system diseases who are judged unsuitable for the study by the investigator...
- 4\. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.
- 5\. people who have used any drugs that alter the activity of drug metabolizing enzymes or transporters within 4 weeks prior to screening, or people...
- 6\. people with severe infection or unexplained infection within 4 weeks before screening.
See the full eligibility criteria
- 1.Obese Chinese 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...
- 2\. Male or female, 18 to 50 years of age at signing the ICF (both inclusive).
- 3\. Body mass index (BMI) within 26-35 kg/m2 (both ends inclusive) at screening.
- 4\. No abnormality or not clinically significant abnormality as judged by the investigator in physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, urinalysis, thyroid function and...
- 5\. people of childbearing potential with no birth plan from the signing of the ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm or ovum donation. Females...
- 1.people with a previous or existing history of heart, liver, kidney, gastrointestinal tract, respiratory system, nervous system, psychiatric disorders, endocrine diseases (except obesity), malignant tumors and other...
- 2\. History or existing diseases that increase the risk of people, such as hypoglycemia, acute or chronic pancreatitis, pancreatic injury, history of symptomatic gallbladder disease; cholelithiasis with high risk of...
- 3\. people with previous or existing clinically significant digestive system diseases who are judged unsuitable for the study by the investigator, such as history of active peptic ulcer or hemorrhage, inflammatory bowel...
- 4\. History or family history of previous or existing medullary thyroid carcinoma, multiple endocrine neoplasia type 2.
- 5\. 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...
- 6\. people with severe infection or unexplained infection within 4 weeks before screening.
- 7\. Major surgery within 6 months prior to screening, or scheduled surgery or hospitalization during the study.
- 8\. people with allergic constitution prior to screening, or a history of bronchial asthma, eczema and other allergic diseases (except mild seasonal allergy), or a history of severe food allergy (such as laryngeal...
- 9\. Use of any prescription drugs, over-the-counter drugs or Chinese herbal medicines within 2 weeks prior to screening; or use of any GLP-1R agonists or drugs with the same mechanism of action to GLP-1R agonists [such...
- 10\. people who have been vaccinated within 1 month before screening or are scheduled for vaccination during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.