A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients (LIGHT)

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.

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.

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Biological: Efsubaglutide Alfa; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Friendship Hospital, Capital Medical University
  • Jinan, China
    • Jinan Central Hospital Affiliated to Shandong First Medical University
  • Shanghai, China, 200030
    • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Fully understood the study, signed the informed consent.
• Male or female patients aged from 18 to 75 years at the time of signing informed consent.
• Body mass index (BMI) greater than or equal to 28 kg/sqm or greater than or equal to 24 kg/sqm with the presence of at least one of the following weight-related comorbidities: prediabetic state, hypertension, dyslipidemia, non-alcoholic steatohepatitis (NASH), obstructive sleep apnea or cardiovascular disease.
• A self-reported change in body weight less than 5% within 90 days before screening irrespective.

Exclusion Criteria:

• Glycated hemoglobin (HbA1c) greater than or equal to 6.5%, or previously diagnosed with type 1 diabetes or type 2 diabetes.
• Have history of clinically significant abnormal gastric emptying, severe chronic gastrointestinal diseases, long-term use of medications that directly affect gastrointestinal peristalsis, or gastrointestinal surgery within 6 months prior to screening, and deemed unsuitable for participation by the investigator.
• Have history of hyperthyroidism or hypothyroidism, or a thyroid-stimulating hormone (TSH) level below the lower limit or above 1.5 times the upper limit of the normal range.
• Calcitonin greater than or equal to 50 ng/L, or have history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B syndrome, or a related family history.
• Any other condition that, in the judgment of the researchers, may affect the patient's ability to provide informed consent or comply with the trial protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efsubaglutide Alfa 5mg; 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.	Biological: Efsubaglutide Alfa; Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.; Other Names: Supaglutide; Other: Placebo; Placebo subcutaneous injection weekly
Experimental: Efsubaglutide Alfa 7.5mg; 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.	Biological: Efsubaglutide Alfa; Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.; Other Names: Supaglutide; Other: Placebo; Placebo subcutaneous injection weekly
Experimental: Efsubaglutide Alfa 10mg; 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.	Biological: Efsubaglutide Alfa; Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.; Other Names: Supaglutide; Other: Placebo; Placebo subcutaneous injection weekly
Experimental: Efsubaglutide Alfa 15mg; 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.	Biological: Efsubaglutide Alfa; Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.; Other Names: Supaglutide; Other: Placebo; Placebo subcutaneous injection weekly
Experimental: Efsubaglutide Alfa 20mg; 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.	Biological: Efsubaglutide Alfa; Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.; Other Names: Supaglutide; Other: Placebo; Placebo subcutaneous injection weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline	Baseline, 4 weeks after the target dose
Adverse Event	Numbers of Adverse Event	Adverse events occurring within 4 weeks of the last dose from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Proportion of subjects with a weight loss of ≥10% or ≥15% from baseline, Change from baseline in weight	Baseline, 4 weeks after the target dose
BMI	Change from baseline in BMI	Baseline, 4 weeks after the target dose
Waist circumference	Change from baseline in Waist circumference	Baseline, 4 weeks after the target dose
Hip circumference	Change from baseline in Hip circumference	Baseline, 4 weeks after the target dose
Waist Hip Rate (WHR)	Change from baseline in Waist Hip Rate (WHR)	Baseline, 4 weeks after the target dose
Diastolic pressure	Change from baseline in Diastolic pressure	Baseline, 4 weeks after the target dose
Systolic pressure	Change from baseline in Systolic pressure	Baseline, 4 weeks after the target dose
Triglyceride	Change from baseline in Triglyceride	Baseline, 4 weeks after the target dose
Total Cholesterol	Change from baseline in Total Cholesterol	Baseline, 4 weeks after the target dose
High Density Lipoprotein Cholesterol （HDL-C）	Change from baseline in High Density Lipoprotein Cholesterol （HDL-C）	Baseline, 4 weeks after the target dose
Low-Density Lipoprotein Cholesterol （LDL-C）	Change from baseline in Low-Density Lipoprotein Cholesterol （LDL-C）	Baseline, 4 weeks after the target dose
HbA1c	Change from baseline in HbA1c	Baseline, 4 weeks after the target dose
Fasting Blood Insulin	Change from baseline in Fasting Blood Insulin	Baseline, 4 weeks after the target dose
HOMA-IR	Change from baseline in HOMA-IR	Baseline, 4 weeks after the target dose
Body Fat	Change in body fat from baseline measured with a body fat scale.	Baseline, 4 weeks after the target dose

Collaborators and Investigators

• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
• Collaborators: Beijing Friendship Hospital; Jinan Central Hospital; Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Principal Investigator: Weiping Jia, M.D,Ph. D, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2024
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): November 18, 2024

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Actual): December 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: YN011-W201 (Other Identifier: Guangzhou Innogen Pharmaceutical Group Co., Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No