A Study of the Efficacy and Safety of Efsubaglutide Alfa in Overweight or Obesity Patients
NCT ID: NCT06732960
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2024-04-21
2024-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Efsubaglutide Alfa 5mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
Efsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Placebo
Placebo subcutaneous injection weekly
Efsubaglutide Alfa 7.5mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
Efsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Placebo
Placebo subcutaneous injection weekly
Efsubaglutide Alfa 10mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
Efsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Placebo
Placebo subcutaneous injection weekly
Efsubaglutide Alfa 15mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
Efsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Placebo
Placebo subcutaneous injection weekly
Efsubaglutide Alfa 20mg
10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo.
Efsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Placebo
Placebo subcutaneous injection weekly
Interventions
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Efsubaglutide Alfa
Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly.
Placebo
Placebo subcutaneous injection weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
OTHER
Beijing Friendship Hospital
OTHER
Jinan Central Hospital
OTHER
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Weiping Jia, M.D,Ph. D
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Locations
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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
Countries
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Other Identifiers
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YN011-W201
Identifier Type: OTHER
Identifier Source: secondary_id
YN011-W201
Identifier Type: -
Identifier Source: org_study_id
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