Recruiting
Phase 1

BGM1812

Sponsor:

BrightGene Bio-Medical Technology Co., Ltd.

Code:

NCT07224399

Conditions

Healhty

Overweight or Obesity

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

BGM1812

Placebo

BGM1812

Placebo

Study Details

Brief summary:

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.

Conditions

Healhty

Overweight or Obesity

Study ID

NCT07224399

Start date

Oct 9, 2025

Status verified date

Aug, 2025

Completion date

May 15, 2026

Anticipated

Primary completion date

May 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

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

1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR
2. 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 (For Cohort 3- 6); OR
3. Between ≥ 23.0 kg/m2 and < 27.0 kg/m2 healthy subjects (for Cohort 1 and Cohort 2)
  • Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening

Exclusion Criteria:

  • Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
  • Known type I/II diabetes.
  • Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight.
  • History of acute or chronic pancreatitis or pancreatic injury.
  • Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BGM1812 (Part A)

Single ascending doses of BGM1812 administered subcutaneously (SC).

placebo comparator: Placebo (Part A)

Placebo administered SC.

experimental: BGM1812 (Part B)

Multiple ascending doses of BGM1812 administered SC.

placebo comparator: Placebo (Part B)

Placebo administered SC.

Interventions

BGM1812

Administered SC.

Placebo

Administered SC.

BGM1812

Administered SC.

Placebo

Administered SC.

Primary outcome measure

  • Number of treatment adverse events [ Time Frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B) ]

Central Contacts and Locations

Locations

Pharmaron CPC, Inc

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

More Information

Sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Last update posted

Nov 6, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BrightGene Bio-Medical Technology Co., Ltd. on 2025-11-06.