Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

NCT03986008 | Unknown Phase 3

• 1 other identifier: 2019050125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Weight Change at 3 months

  Measured in kilograms

  baseline and 3 months

• Gut microbiota composition

  Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).

  3 months

Secondary Outcomes (14)

• Change in waist circumference

  baseline and 3 months

• Change in systolic blood pressure

  baseline and 3 months

• Change in diastolic blood pressure

  baseline and 3 months

• Change in HbA1c

  baseline and 3 months

• Change in plasma glucose

  baseline and 3 months

Study Arms (2)

Benaglutide

EXPERIMENTAL

Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal.

Drug: Benaglutide

Liraglutide

ACTIVE COMPARATOR

Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day.

Drug: Liraglutide

Interventions

Benaglutide DRUG

The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.

Also known as: rhGLP-1(7-36)

Benaglutide

Liraglutide DRUG

The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.

Also known as: Victoza

Liraglutide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 65 years (to the date of screening)；
• 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).
• Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
• Weight stable for more than 3 months (weight fluctuations \<5%).

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jing Wu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wu

CONTACT

+8613574120508; wujing0731@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: December 1, 2019
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)