Clinical trials

11

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Condition / disease
Location
Status: Not yet recruiting

A Study to Evaluate Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes

To evaluate the efficacy of BGM0504 tablets compared with placebo in reducing body weight in overweight or obese participants without diabetes after 20 weeks of treatment.

Participants needed: 200
Trial details
Phase: Phase 2Age: 18-55Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Jun 22, 2026Locations: 1
Eligibility criteria

○ Participants must be Chinese, non-diabetic, overweight or obese individuals ag... [+5]

● (Medical Inquiry) Individuals with a history of severe drug allergy (especiall... [+36]

Status: Recruiting

A Study of BGM0504 Tablets in Healthy Chinese Subjects

A randomized, open-label, multiple-dose study to evaluate the effects of high-fat meals and different administration conditions (including water intake and fasting time) on the pharmacokinetics of BGM0504 tablets at a dose of 20mg in healthy Chinese participants and to assess its safety and tolerability.

Participants needed: 144
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: May 5, 2026Locations: 1
Eligibility criteria

○ Between the ages of 18 and 55 years (inclusive) at the time of screening, both... [+4]

● (Medical Inquiry) Individuals with a history of severe drug allergies (especia... [+19]

Status: Recruiting

Bioequivalence Study of BGM0504 Injection

This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).

Participants needed: 144
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Feb 3, 2026Locations: 1
Eligibility criteria

Age 18-55 years (inclusive). [+3]

History of severe allergies or severe specific allergic diseases/history (asthma... [+9]

Status: Recruiting

A Study of BGM1812 Injection in Healthy and Non-diabetic Overweight or Obese Chinese Participants

The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Dec 19, 2025Locations: 1
Eligibility criteria

Between the ages of 18 and 65 years (inclusive) at the time of screening , healt... [+5]

Those with a history of severe drug allergies (especially those with known or su... [+8]

Status: Recruiting

A Study of BGM0504 Tablets 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.

Participants needed: 75
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Nov 20, 2025Locations: 1
Eligibility criteria

Between the ages of 18 and 65 years (inclusive) at the time of screening , healt... [+5]

Those with a history of severe drug allergies (especially those with known or su... [+15]

Status: Recruiting

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Nov 6, 2025Locations: 1
Eligibility criteria

Capable of understanding the written informed consent document; willingly provid... [+4]

Have allergic predisposition (allergic to 3 or more foods or drugs), or are alle... [+4]

Status: Recruiting

A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

Participants needed: 477
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Oct 28, 2025Locations: 4
Eligibility criteria

○ Have been diagnosed with type 2 diabetes mellitus (T2DM); [+4]

○ Previous diagnosis of type 1 diabetes, special type diabetes; [+7]

Status: Recruiting

A Study of BGM0504 in Participants With Obesity

To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.

Participants needed: 90
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Oct 28, 2025Locations: 1
Eligibility criteria

● Able and willing to provide a written informed consent. [+3]

●History of chronic or acute pancreatitis. [+8]

Status: Recruiting

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

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.

Participants needed: 80
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Sep 19, 2025Locations: 1
Eligibility criteria

Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR [+3]

Have allergic predisposition (allergic to 3 or more foods or drugs), or are alle... [+5]

Status: Recruiting

A Study of BGM0504 in Participants with Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Participants needed: 537
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Feb 7, 2025Locations: 1
Eligibility criteria

■ Have been diagnosed with type 2 diabetes mellitus (T2DM); [+4]

■ Previous diagnosis of type 1 diabetes, special type diabetes; [+7]

Status: Recruiting

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Participants needed: 207
Trial details
Phase: Phase 3Age: 18-75Biological sex: AllType: InterventionalSponsor: BrightGene Bio-Medical Technology Co., Ltd.Updated: Feb 7, 2025Locations: 1
Eligibility criteria

☑ Have been diagnosed with type 2 diabetes mellitus (T2DM); [+4]

■ Previous diagnosis of type 1 diabetes, special type diabetes ; [+7]