Efsubaglutide Alfa
BiologicalEfsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Other names: Supaglutide
NCT Number: NCT06732960
This is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa at difference dose range once-weekly in patients with Overweight or Obesity.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Beijing Friendship Hospital, Capital Medical University, Beijing, China
This study will look at the adverse events and the change in participants' body weight from the start of the study to the end. Weight loss in participants taking Efsubaglutide Alfa will be compared to weight loss in participants taking placebo.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Other names: Supaglutide
Placebo subcutaneous injection weekly
Time frame: Baseline, 4 weeks after the target dose
Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline
Time frame: Adverse events occurring within 4 weeks of the last dose from baseline
Numbers of Adverse Event
Time frame: Baseline, 4 weeks after the target dose
Proportion of subjects with a weight loss of ≥10% or ≥15% from baseline, Change from baseline in weight
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in BMI
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Waist circumference
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Hip circumference
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Waist Hip Rate (WHR)
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Diastolic pressure
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Systolic pressure
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Triglyceride
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Total Cholesterol
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in HbA1c
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in Fasting Blood Insulin
Time frame: Baseline, 4 weeks after the target dose
Change from baseline in HOMA-IR
Time frame: Baseline, 4 weeks after the target dose
Change in body fat from baseline measured with a body fat scale.
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Other
A Randomized, Double-Blind, Placebo-controlled Study of Efsubaglutide Alfa on Weight Management in Subjects With Overweight or Obesity to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy.
Acronym: LIGHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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