A Study of TG103 Injection in Non-diabetic Overweight or Obesity (NCT05997576) | Clinical Trial Compass
CompletedPhase 3
A Study of TG103 Injection in Non-diabetic Overweight or Obesity
China675 participantsStarted 2023-11-22
Plain-language summary
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3 study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased physical activity).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female, 18 years ≤ age ≤ 75 years.
* Body Mass Index (BMI) ≥ 28 kg/m\^2, or 24 kg/m\^2 \< BMI ≤ 28 kg/m\^2 with at least one of obesity-related complications.
* Regular diet and exercise and stable body weight (i.e., self-reported body weight change \< 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
* Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.
* Be able to understand the trial and complete the procedures, and be voluntary to participate in this study and sign the informed consent.
Exclusion Criteria:
* History of type 2 diabetes, type 1 diabetes or hypoglycemia.
* Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.
* Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.
* Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.
* Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.
* Participation in any clinical trial to receive treatment within 12 weeks before screening, or participation in clinical trial to receive TG103 before screening.
* History …
What they're measuring
1
Proportion of participants with weight loss of ≥ 5% at week 40
Timeframe: From baseline to week 40
2
Relative percentage change from baseline in body weight at week 40