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

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Overweight or Obesity; Healhty

Treatments: Drug: Placebo; Drug: BGM1812

Study type: Interventional

Funder types: Industry

Identifiers

NCT07224399

BGM1812-P1-CPK01-US

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

BGM1812 (Part A)

Experimental group

Description:

Single ascending doses of BGM1812 administered subcutaneously (SC).

Treatment:

Drug: BGM1812

Drug: BGM1812

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Drug: Placebo

BGM1812 (Part B)

Experimental group

Description:

Multiple ascending doses of BGM1812 administered SC.

Treatment:

Drug: BGM1812

Drug: BGM1812

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Drug: Placebo