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Official title A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects
ClinicalTrials.gov ID: NCT07239973
What this study is testing
What is BGM0504 tablets?
BGM0504 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
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
- A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 55. Healthy volunteers may be eligible.
You may be able to join if
- Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese people , both male and female;
- Healthy people , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI \< 28 kg/m²（BMI = weight/height²）;
- Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI \< 28.0 kg/m²;
- (Medical Inquiry) Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening.
- Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent...
You likely can't join if
- Those with a history of severe drug allergies (especially those with known or suspected allergies to the active ingredients and excipients of BGM0504...
- people with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
- At the screening/baseline period, any one of the laboratory test indicators meets the following criteria:
- fasting serum glucose≥ 7.0mmol/L, or post-prandial glucose (PPG)-2h≥ 11.1mmol/L in oral glucose tolerance test (OGTT); (During screening...
- ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)
- Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.
See the full eligibility criteria
- Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese people , both male and female;
- Healthy people , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI \< 28 kg/m²（BMI = weight/height²）;
- Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI \< 28.0 kg/m²;
- (Medical Inquiry) Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening.
- Have no history of mental disorders, be able to communicate smoothly with Investigator, Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing...
- Male people with female partners of reproductive potential must agree to practice abstinence or to use a condom (male subject) plus an additional medically acceptable form of contraception (female partner) for the...
- Those with a history of severe drug allergies (especially those with known or suspected allergies to the active ingredients and excipients of BGM0504 Tablets), or complicated with severe specific allergic...
- people with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
- At the screening/baseline period, any one of the laboratory test indicators meets the following criteria:
- fasting serum glucose≥ 7.0mmol/L, or post-prandial glucose (PPG)-2h≥ 11.1mmol/L in oral glucose tolerance test (OGTT); (During screening, participants with fasting serum glucose ranging from 6.1 to 6.9mmol/L shall...
- ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)
- Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.
- Serum calcitonin level ≥ 35 ng/L (pg/mL);
- Thyroid-stimulating hormone (TSH) \> 6.0mIU/L or \< 0.4mIU/L;
- Fasting triglycerides ≥ 5.64mmol/L (500 mg/dL);
- Hemoglobin (Hgb) \< 100 g/L (for females) or \< 110 g/L (for males);
- 12-lead ECG shows ventricular heart rate \ 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF\> 470ms for women or \> 450ms for men, pre-excitation syndrome or...
- Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
- Participated in drug or medical device clinical trials and treated with Study Drug (excluding placebo) or medical device intervention within 12 weeks before screening.
- Participants who have received any vaccine within 2 weeks prior to screening, or plan to receive a vaccine during the trial.
- Female participants who are pregnant or lactating, or those with a positive pregnancy test result during the screening period.
- Positive urine drug test or alcohol serum test result at screening or at baseline.
- Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, 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 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kunming, Yunnan, 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.