A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity (NCT06226090) | Clinical Trial Compass
CompletedPhase 2
A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
China314 participantsStarted 2024-02-21
Plain-language summary
This study is a randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle intervention.
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.
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 of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or suspected allergy to TG103 judged by investigator du…
What they're measuring
1
Percentage relative change from baseline in body weight at week 24