Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects

NCT07166081 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BGM0504 Oral-P1-CPK01-US
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-diabetic Overweight or Obese

Outcome Measures

Primary Outcomes (1)

• Number of treatment adverse events

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

  11 weeks

Secondary Outcomes (2)

• Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

  11 weeks

• Change in fasting weight at week 11

  11 weeks

Study Arms (5)

Cohort 1

EXPERIMENTAL

20 mg BGM0504 administered orally

Drug: BGM0504

Cohort 2

EXPERIMENTAL

40 mg BGM0504 administered orally

Drug: BGM0504

Cohort 3

EXPERIMENTAL

60 mg BGM0504 administered orally

Drug: BGM0504

Placebo

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

Cohort 4

EXPERIMENTAL

80mg BGM0504 administered orally

Drug: BGM0504

Interventions

BGM0504 DRUG

Administered orally

Cohort 1

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• Known type I/II diabetes.
• History of acute or chronic pancreatitis or pancreatic injury.
• History of drug abuse or alcoholism at screening.

Sponsors & Collaborators

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

Study Sites (1)

Pharmaron CPC, Inc

Baltimore, Maryland, 21201, United States

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

MB ChB

CONTACT

240-673-0900; mohamed.al-ibrahim@pharmaron.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: September 3, 2025
• First Posted: September 10, 2025
• Study Start: August 11, 2025
• Primary Completion: January 12, 2026
• Study Completion (Estimated): May 13, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-08

Locations

US (1)