Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients

What Was Tested

The trial (phase 3) is built around Liraglutide.

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

It had two arms (groups): Benaglutide (experimental) and Liraglutide (active comparator).

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.

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: pregnant female; 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-12-01 with completion listed for 2021-12-23.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight Change at 3 months (time frame: baseline and 3 months). Gut microbiota composition (time frame: 3 months).

It also tracked 14 secondary outcomes, for example Change in waist circumference, Change in systolic blood pressure, Change in diastolic blood pressure, Change in HbA1c, Change in plasma glucose and Change in insulin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.