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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

ConditionsHealhtyOverweight or Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGM1812

    Drug

    Administered SC.

  • Placebo

    Drug

    Administered SC.

  • BGM1812

    Drug

    Administered SC.

  • Placebo

    Drug

    Administered SC.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: BGM1812 (Part A)Experimental treatment 1 intervention
Group B: Placebo (Part A)Placebo comparator 1 intervention
Group C: BGM1812 (Part B)Experimental treatment 1 intervention
Group D: Placebo (Part B)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of treatment adverse events

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

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

Secondary outcomes

1

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

PK: AUC of BGM1812

Time frame
Predose through week 6 (Part A) & week 9 (Part B)
2

PK: Maximum Observed Concentration (Cmax) of BGM1812

PK: Cmax of BGM1812

Time frame
Predose through week 6 (Part A) & week 9 (Part B)
3

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

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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