NCT07166081CompletedPhase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects
A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral administrations in non-diabetic overweight or obese adult subjects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 3 Sept 2025
- Start date
- 11 Aug 2025
- Primary completion date
- 16 Mar 2026
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07166081
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 80
- From 11 Aug 2025 to the primary completion date, 16 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
- Have received drugs that have an impact on body weight within 12 weeks before screening.
Other illness
- Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
- Known type I/II diabetes.
- History of acute or chronic pancreatitis or pancreatic injury.
- History of drug abuse or alcoholism at screening.
Who the study is looking for
- Body mass index (BMI) meeting one of the following requirements:
- Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
- Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia
- Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening
- Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pharmaron CPC, Inc. Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.