Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

Last updated: April 7, 2021
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03986008
2019050125
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 65 years (to the date of screening);
  2. The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
  3. Nearly a month have not used weight-related drugs,including various weight-lossdrugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroiddrugs,etc;Or recently used weight-related drugs but the stable dose was more than 1month,and the drug dose remained constant or decreased during the trial.
  4. Weight stable for more than 3 months (weight fluctuations <5%).

Exclusion

Exclusion Criteria:

  1. pregnant female.
  2. Secondary diseases caused by other diseases: including hypothyroidism, increasedcortisol, hypothalamic and pituitary lesions caused by obesity, all kinds ofdrug-induced obesity, and others.
  3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardialinfarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease orpulmonary insufficiency, renal failure, severe hepatitis.
  4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis,hyperosmolar state of diabetes.
  5. Nearly a month had surgery, trauma, infection and so on.
  6. Limb deformity incomplete, difficult to accurately determine the height, weight andother physical indicators.
  7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).

Study Design

Total Participants: 60
Study Start date:
December 01, 2019
Estimated Completion Date:
December 23, 2021

Connect with a study center

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

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