Health TrialsbyHealthPanel

A Study of BGM0504 Tablets in Healthy and Non-diabetic Overweight or Obese Chinese Subjects

ConditionsHealthyNon-diabetic Overweight or Obese
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

A Randomized, Double-Blind, Placebo-Controlled, Single/Multiple-dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BGM0504 Tablets Orally Administered in Healthy and Non-diabetic Overweight or Obese Chinese Subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;

Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI < 28 kg/m²（BMI = weight/height²）;

Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m²;

(Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.

Disqualifiers

Those with a history of severe drug allergies (especially those with known or suspected allergies to the active ingredients and excipients of BGM0504 Tablets), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.

Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.

fasting serum glucose≥ 7.0mmol/L, or post-prandial glucose (PPG)-2h≥ 11.1mmol/L in oral glucose tolerance test (OGTT); (During screening, participants with fasting serum glucose ranging from 6.1 to 6.9mmol/L shall undergo the OGTT.)

ALT, AST ≥ 2.5 times upper limit of normal (ULN) or total bilirubin ≥ 1.5 times upper limit of normal (ULN)

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGM0504 tablets

    Drug

    Administered p.o.

  • Placebo tablets

    Drug

    Administered p.o.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: BGM0504 tabletsExperimental treatment 1 intervention
Group B: Placebo tabletsExperimental treatment 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
8 weeks

Secondary outcomes

1

Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

Time frame
8 weeks
2

Change in fasting weight at week 8

Time frame
8 weeks

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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