Comparison of Body Weight Change Through Different Smeglutide Administration Methods

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had two arms (groups): standard arm (active comparator) and titration arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

Participants will be randomized into either group.

Who Took Part

Enrollment: 80 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: 18 ≤ age\<75;. Overweight or obesity: meet either one of the following standards. Patients with BMI ≥ 24 kg/m2 and at least one obesity complication (hypertension, hyperlipidemia, apnea syndrome, cardiovascular disease). Simple obese patients with BMI ≥ 28kg/m2. Abdominal obesity, waist circumference ≥ 90 cm for males and ≥ 80 cm for females.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: have a personal or family history of medullary thyroid carcinoma (mtc) or have multiple endocrine neoplasia type 2 (men-2) patients; patients with severe hypersensitivity to smeglutide or any other excipient component; participants in other clinical drug trials in recent three months.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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

The Semaglutide group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Semaglutide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2022-12-01 with completion listed for 2023-12-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): weight change in kilograms (time frame: 16 weeks).

It also tracked 15 secondary outcomes, for example patient compliance in rate, waist hip circumference in centimeter, number of adverse events, appetite change in score, body fat in percentage and body composition of lean mass in kilogram.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 80 people.

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

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