A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects

A Phase 1, 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Non-diabetic Overweight or Obese
• Intervention / Treatment: Drug: BGM0504 tablets; Drug: Placebo tablets

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jianchang He; Phone Number: 13700680697; Email: hejc@yn-cprc.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Recruiting
      • The First Affiliated Hospital of Yunnan University of Chinese Medicine
      • Contact: Rui Qian; Phone Number: 13888185640; Email: Qr740220@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;
• Healthy subjects , 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 and able to comply with the schedule, requirements and restrictions of the study.
• Male subjects 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 duration of the study and for at least 3 months after dosing; must also agree to refrain from sperm donation for at least 3 months post dose

Exclusion Criteria:

• 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 diseases/history, or with a severe allergic constitution.
• Subjects 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:

  1. 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 undergo the OGTT.)
  2. ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)
  3. Glomerular filtration rate (eGFR) ≤ 80 mL/min/1.73 m2(using CKD-EPI formula) or positive urine protein 2+ or more.
  4. Serum calcitonin level ≥ 35 ng/L (pg/mL);
  5. Thyroid-stimulating hormone (TSH) > 6.0mIU/L or < 0.4mIU/L;
  6. Fasting triglycerides ≥ 5.64mmol/L (500 mg/dL);
  7. Hemoglobin (Hgb) < 100 g/L (for females) or < 110 g/L (for males);
• 12-lead ECG shows ventricular heart rate < 50 beats/min or > 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 other significant arrhythmias.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGM0504 tablets; Oral administration once daily	Drug: BGM0504 tablets; Administered p.o.
Experimental: Placebo tablets; Placebo Oral administration once daily	Drug: Placebo tablets; Administered p.o.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment adverse events	The relationship of each adverse event to the investigational product was assessed by the investigator	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic endpoint: Concentration of BGM0504 in plasma	8 weeks
Change in fasting weight at week 8	8 weeks

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: BGM0504-CPK-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No