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A Study of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents

ConditionsAdolescents With ObesityAdolescents With Overweight & Weight-related Comorbidities
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorHangzhou Sciwind Biosciences Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ecnoglutide Injection

    Drug

    Subcutaneous injection

  • placebo with matching volume

    Drug

    Subcutaneous injection

Treatment groups

192 Participants
are divided into 4 treatment groups
Group A: Ecnoglutide Injection Dose 1Experimental treatment 1 intervention
Group B: Ecnoglutide Injection Dose 2Experimental treatment 1 intervention
Group C: Ecnoglutide Injection Dose 3Experimental treatment 1 intervention
Group D: placeboPlacebo comparator 1 intervention

Trial outcomes

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

Include percent change and absolute change

Time frame
Baseline, week 52
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Sciwind Biosciences Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: