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Recruiting 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

Phase I Interventional Healhty Overweight or Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BGM1812, Placebo, BGM1812, Placebo.
Who it may be relevant to
Registry conditions: Healhty, Overweight or Obesity. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug BGM1812
    Administered SC.
  • Drug Placebo
    Administered SC.
  • Drug BGM1812
    Administered SC.
  • Drug Placebo
    Administered SC.

Primary outcome measures

  • Number of treatment adverse events [Time frame: Predose up to 6 weeks (Part A) & 9 weeks (Part B)]
Secondary outcome measures (3)
  • 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: Maximum Observed Concentration (Cmax) of BGM1812 [Time frame: Predose through week 6 (Part A) & week 9 (Part B)]
  • Pharmacodynamics (PD): Change from baseline in fasting body weight [Time frame: Predose through week 6 (Part A) & week 9 (Part B)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Pharmaron CPC, Inc — Baltimore

Identifiers

NCT: NCT07224399 · BGM1812-P1-CPK01-US

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗