Evaluating BGM0504 in overweight or obese individuals

A Single Center, Open-label, Fixed Sequence Trial, Investigating the Influence of BGM0504 Injection on Gastric Emptying and Pharmacokinetics of Metformin and Warfarin in Overweight or Obese Participants

This study is testing if an injection called BGM0504 can change how quickly the stomach empties and how well the diabetes and blood thinner medications metformin and warfarin work in people who are overweight or obese.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (industry)
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT06920056 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effects of BGM0504 injection on gastric emptying and the pharmacokinetics of metformin and warfarin in participants who are overweight or obese. It involves administering BGM0504 alongside these medications to understand how it influences their absorption and metabolism. Participants will be monitored throughout the study to gather data on these interactions and their overall health. The study is interventional and is classified as Phase 1, focusing on safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a body mass index (BMI) of 24 kg/m² to 28 kg/m² or greater than 28 kg/m².

Not a fit: Patients with a history of chronic or acute pancreatitis, severe drug allergies, or certain malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for overweight or obese patients, particularly in managing their medication regimens.

How similar studies have performed: While this specific approach is novel, similar studies exploring the pharmacokinetics of medications in overweight or obese populations have shown varying degrees of success.

Eligibility criteria

Inclusion Criteria: √ Have a body mass index (BMI) of greater than or equal to (≥)28 kilogram per square meter (kg/m²) or ≥24 kg/m2 and less than (\<) 28 kg/m².

√ Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff.

Exclusion Criteria: √ History of chronic or acute pancreatitis.

* History of severe drug allergy or specific allergic disease or severe allergies.
* Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2(MEN-2).
* History of malignant tumors \[except carcinoma in situ with no recurrence within 5 years (except for malignant melanoma in situ), skin basal cell carcinoma and squamous cell carcinoma\].
* Suspected or confirmed history of alcohol or drug abuse;
* Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
* Donation or loss of 400 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 3 months after the end of the trial.
* Pregnant or lactating woman.
* Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

Where this trial is running

Kunming, Yunnan

• The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine) — Kunming, Yunnan, China (RECRUITING)

Study contacts

• Study coordinator: jianzhang He

Conditions: Overweight or Obese