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NCT Number: NCT07836270

A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents

The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

About this study

In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous Ecnoglutide injection or placebo, for up to 52 weeks

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At screening, the BMI meets the obesity criteria specified in 'WS/T586-2018 Screening for Overweight and Obesity in School-Aged Children and Adolescents', or it meets the overweight criteria and is accompanied by at least one weight-related comorbidity: hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, etc.
  • Participant with body weight loss <5% by diet and exercise for at least 3 months before screening (per self, parental/legal report).

Exclusion criteria

  • Pre-adolescent participants (Tanner phase 1);
  • History of receiving weight loss surgery or plan to undergo weight loss surgery during the study period (excluding acupuncture-based weight loss, liposuction, or abdominal fat removal procedures conducted more than 1 year prior to screening);
  • Known secondary obesity, including but not limited to that resulting from: hypercortisolism (e.g. Cushing's syndrome), pituitary or hypothalamic lesions, or monogenic obesity, etc.;
  • Diagnosis with any type of diabetes;
  • History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury;
  • History of using any approved or unapproved drugs for weight loss, antidiabetic drugs, long-term systemic glucocorticoids (more than 14 days), within 3 months prior to screening;

Treatment and study plan

Ecnoglutide Injection

Drug

Subcutaneous injection

placebo with matching volume

Drug

Subcutaneous injection

Primary outcomes

  1. Percent change in Body Mass Index (BMI)

    Time frame: Baseline, week 40

Secondary outcomes

  1. Percentage of participants with ≥5% of BMI reduction

    Time frame: Baseline, week 40 and week 52

  2. Change in BMI

    Time frame: Baseline, week 52

    Include percent change and absolute change

  3. Percentage of participants with ≥10% of BMI reduction

    Time frame: Baseline, week 52

  4. Percentage of participants with ≥15% of BMI reduction

    Time frame: Baseline, week 52

  5. Percentage of participants with ≥20% of BMI reduction

    Time frame: Baseline, week 52

  6. Change in body weight

    Time frame: Baseline, week 52

    Include percent change and absolute change

  7. Change in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline, week 52

  8. Change in Fasting Plasma Glucose (FPG)

    Time frame: Baseline, week 52

  9. Change in Fasting Insulin

    Time frame: Baseline, week 52

  10. Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)

    Time frame: Baseline, week 52

  11. Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)

    Time frame: Baseline, week 52

  12. Change in lipid profile

    Time frame: Baseline, week 52

    Include triglycerides, LDL-C, HDL-C, total cholesterol

  13. Change in liver enzymes

    Time frame: Baseline, week 52

    Include alanine aminotransferase, aspartate aminotransferase and gamma-glutamyl transferase

  14. Adverse events

    Time frame: From week1 to week 57

    Incidence and severity

  15. Trough concentration of ecnoglutide

    Time frame: From baseline to week 57 (EOS)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hangzhou Sciwind Biosciences Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Efficacy of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents (SLIMMER-YOUNG)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

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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