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

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Overweight or Obesity

Interventions

Efsubaglutide AlfaBIOLOGICAL

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

PlaceboOTHER

Placebo subcutaneous injection weekly

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (3)

Beijing Friendship Hospital, Capital Medical University

Beijing, China, China

Jinan Central Hospital Affiliated to Shandong First Medical University

Jinan, China, China

Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

Shanghai, China, China

Outcomes

Primary Outcomes

Weight

Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline

Time frame: Baseline, 4 weeks after the target dose

Adverse Event

Numbers of Adverse Event

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

Secondary Outcomes

Weight

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

BMI

Change from baseline in BMI

Time frame: Baseline, 4 weeks after the target dose

Waist circumference

Change from baseline in Waist circumference

Time frame: Baseline, 4 weeks after the target dose

Hip circumference

Change from baseline in Hip circumference

Time frame: Baseline, 4 weeks after the target dose

Waist Hip Rate (WHR)

Change from baseline in Waist Hip Rate (WHR)

Time frame: Baseline, 4 weeks after the target dose

Diastolic pressure

Change from baseline in Diastolic pressure

Time frame: Baseline, 4 weeks after the target dose

Systolic pressure

Data from ClinicalTrials.gov

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