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NCT Number: NCT07224399

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC, Inc

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

MD, MPH, FACP

CONTACT

[email protected]

410-706-8877

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); 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 (For Cohort 3- 6); OR
  • 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.

Treatment and study plan

BGM1812

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  1. Number of treatment adverse events

    Time frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B)

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

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812

    Time frame: Predose through week 6 (Part A) & week 9 (Part B)

    PK: AUC of BGM1812

  2. PK: Maximum Observed Concentration (Cmax) of BGM1812

    Time frame: Predose through week 6 (Part A) & week 9 (Part B)

    PK: Cmax of BGM1812

  3. Pharmacodynamics (PD): Change from baseline in fasting body weight

    Time frame: Predose through week 6 (Part A) & week 9 (Part B)

    Pharmacodynamics (PD): Change from baseline in fasting body weight

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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