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Completed

NCT Number: NCT06732960

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Efsubaglutide Alfa

Biological

Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.

Other names: Supaglutide

Placebo

Other

Placebo subcutaneous injection weekly

Primary outcomes

  1. Weight

    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

  2. Adverse Event

    Time frame: Adverse events occurring within 4 weeks of the last dose from baseline

    Numbers of Adverse Event

Secondary outcomes

  1. Weight

    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

  2. BMI

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in BMI

  3. Waist circumference

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Waist circumference

  4. Hip circumference

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Hip circumference

  5. Waist Hip Rate (WHR)

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Waist Hip Rate (WHR)

  6. Diastolic pressure

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Diastolic pressure

  7. Systolic pressure

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Systolic pressure

  8. Triglyceride

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Triglyceride

  9. Total Cholesterol

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Total Cholesterol

  10. High Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in High Density Lipoprotein Cholesterol (HDL-C)

  11. Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

  12. HbA1c

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in HbA1c

  13. Fasting Blood Insulin

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in Fasting Blood Insulin

  14. HOMA-IR

    Time frame: Baseline, 4 weeks after the target dose

    Change from baseline in HOMA-IR

  15. Body Fat

    Time frame: Baseline, 4 weeks after the target dose

    Change in body fat from baseline measured with a body fat scale.

Sponsors and collaborators

Lead sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Other

Collaborators

  • Beijing Friendship Hospital
  • Jinan Central Hospital
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2024
Registry last updated
Apr 2, 2025

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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