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

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-diabetic Overweight or Obese

In brief

This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.

Key facts

Study ID

NCT06714955

Run by

BrightGene Bio-Medical Technology Co., Ltd.

People needed

30

Starts

2024-10-21

Expected to finish

2025-03-03

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome
• Have a stable body weight (<5% self-reported change during the previous 8 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.
• Surgical treatment for obesity.
• Known type I/II diabetes.
• History of acute or chronic pancreatitis or pancreatic injury.
• History of drug abuse or alcoholism at screening.

Where it is running

• Pharmaron CPC, Inc — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.