Clinical trial NCT06732960: A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight or Obesity
Lead sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Beijing Friendship Hospital
name: Jinan Central Hospital
First posted: 2024-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight
timeFrame: Baseline, 4 weeks after the target dose
measure: Adverse Event
timeFrame: Adverse events occurring within 4 weeks of the last dose from baseline
Secondary outcomes:
measure: Weight
timeFrame: Baseline, 4 weeks after the target dose
measure: BMI
timeFrame: Baseline, 4 weeks after the target dose
measure: Waist circumference
timeFrame: Baseline, 4 weeks after the target dose
measure: Hip circumference
timeFrame: Baseline, 4 weeks after the target dose
measure: Waist Hip Rate (WHR)
timeFrame: Baseline, 4 weeks after the target dose
measure: Diastolic pressure
timeFrame: Baseline, 4 weeks after the target dose
measure: Systolic pressure
timeFrame: Baseline, 4 weeks after the target dose
measure: Triglyceride
timeFrame: Baseline, 4 weeks after the target dose
measure: Total Cholesterol
timeFrame: Baseline, 4 weeks after the target dose
measure: High Density Lipoprotein Cholesterol （HDL-C）
timeFrame: Baseline, 4 weeks after the target dose
measure: Low-Density Lipoprotein Cholesterol （LDL-C）
timeFrame: Baseline, 4 weeks after the target dose
measure: HbA1c
timeFrame: Baseline, 4 weeks after the target dose
measure: Fasting Blood Insulin
timeFrame: Baseline, 4 weeks after the target dose
measure: HOMA-IR
timeFrame: Baseline, 4 weeks after the target dose
measure: Body Fat
timeFrame: Baseline, 4 weeks after the target dose
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated to Shandong First Medical University
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
name: Weiping Jia, M.D,Ph. D
role: PRINCIPAL_INVESTIGATOR
References: