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

NCT07224399 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BGM1812-P1-CPK01-US
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment adverse events

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

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

Secondary Outcomes (3)

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

  Predose through week 6 (Part A) & week 9 (Part B)

• PK: Maximum Observed Concentration (Cmax) of BGM1812

  Predose through week 6 (Part A) & week 9 (Part B)

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

  Predose through week 6 (Part A) & week 9 (Part B)

Study Arms (4)

BGM1812 (Part A)

EXPERIMENTAL

Single ascending doses of BGM1812 administered subcutaneously (SC).

Drug: BGM1812

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

BGM1812 (Part B)

EXPERIMENTAL

Multiple ascending doses of BGM1812 administered SC.

Drug: BGM1812

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

BGM1812 DRUG

Administered SC.

BGM1812 (Part A)

Placebo DRUG

Administered SC.

Placebo (Part A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

Pharmaron CPC, Inc

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 4, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-08

Locations

US (1)