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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2025-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-diabetic Overweight or Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Drug: BGM0504 Administered SC

Group Type EXPERIMENTAL

Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Intervention Type DRUG

Drug: BGM0504 Administered SC

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

Drug: BGM0504 Administered SC

Group Type EXPERIMENTAL

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

Intervention Type DRUG

Drug: BGM0504 Administered SC

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Drug: Placebo Administered SC

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Intervention Type DRUG

Drug: Placebo Administered SC

Interventions

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Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Drug: BGM0504 Administered SC

Intervention Type DRUG

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

Drug: BGM0504 Administered SC

Intervention Type DRUG

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Drug: Placebo Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) meeting one of the following requirements:

1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
2. 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No