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

NCT07239973 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BGM0504-CPK-101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Non-diabetic Overweight or Obese

Outcome Measures

Primary Outcomes (1)

• Number of treatment adverse events

  The relationship of each adverse event to the investigational product was assessed by the investigator

  8 weeks

Secondary Outcomes (2)

• Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

  8 weeks

• Change in fasting weight at week 8

  8 weeks

Study Arms (2)

BGM0504 tablets

EXPERIMENTAL

Oral administration once daily

Drug: BGM0504 tablets

Placebo tablets

EXPERIMENTAL

Placebo Oral administration once daily

Drug: Placebo tablets

Interventions

BGM0504 tablets DRUG

Administered p.o.

BGM0504 tablets

Placebo tablets DRUG

Administered p.o.

Placebo tablets

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.)
• 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);
• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine

Kunming, Yunnan, 650000, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jianchang He

CONTACT

13700680697; hejc@yn-cprc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 20, 2025
• Study Start: October 21, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

CN (1)