Overweight or Obesity
Conditions
Brief summary
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.
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.
Interventions
BIOLOGICALEfsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
OTHERPlacebo
Placebo subcutaneous injection weekly
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Beijing Friendship Hospital
Jinan Central Hospital
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline, 4 weeks after the target dose | Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline |
| Adverse Event | Adverse events occurring within 4 weeks of the last dose from baseline | Numbers of Adverse Event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Baseline, 4 weeks after the target dose | Change from baseline in Waist circumference |
| Hip circumference | Baseline, 4 weeks after the target dose | Change from baseline in Hip circumference |
| Waist Hip Rate (WHR) | Baseline, 4 weeks after the target dose | Change from baseline in Waist Hip Rate (WHR) |
| Diastolic pressure | Baseline, 4 weeks after the target dose | Change from baseline in Diastolic pressure |
| Systolic pressure | Baseline, 4 weeks after the target dose | Change from baseline in Systolic pressure |
| Triglyceride | Baseline, 4 weeks after the target dose | Change from baseline in Triglyceride |
| Weight | 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 |
| High Density Lipoprotein Cholesterol （HDL-C） | Baseline, 4 weeks after the target dose | Change from baseline in High Density Lipoprotein Cholesterol （HDL-C） |
| Low-Density Lipoprotein Cholesterol （LDL-C） | Baseline, 4 weeks after the target dose | Change from baseline in Low-Density Lipoprotein Cholesterol （LDL-C） |
| HbA1c | Baseline, 4 weeks after the target dose | Change from baseline in HbA1c |
| Fasting Blood Insulin | Baseline, 4 weeks after the target dose | Change from baseline in Fasting Blood Insulin |
| HOMA-IR | Baseline, 4 weeks after the target dose | Change from baseline in HOMA-IR |
| Body Fat | Baseline, 4 weeks after the target dose | Change in body fat from baseline measured with a body fat scale. |
| Total Cholesterol | Baseline, 4 weeks after the target dose | Change from baseline in Total Cholesterol |
| BMI | Baseline, 4 weeks after the target dose | Change from baseline in BMI |
Countries
China
Outcome results
None listed