PEG-rhGH and Semaglutide Combination Therapy in Non-Diabetic Obese Adults

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had two arms (groups): PEG-rhGH Injection + Semaglutide Injection (experimental) and Semaglutide Injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 212 planned participants were the target.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Age between 18 years (minimum age) and 50 years (maximum age), inclusive. Gender: Male or female, with a ratio of male to female being 2:1;. Body Mass Index (BMI) ≥28 kg/m²;. No prior use of semaglutide injection or antidiabetic medications;. Free Thyroxine (FT4) levels within normal range at screening;.

The full record lists 8 inclusion and 30 exclusion criteria; among the exclusions: unable to accept regular follow-up;; those who have difficulty with self-injection;; history of allergic reactions to the study drug or similar drugs;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

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

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The change in lean body weight (kg) from baseline (time frame: Week 40).

It also tracked 10 secondary outcomes, for example Change in lean body mass percentage (%), Change in appendicular muscle mass (kg), Change in trunk muscle mass (kg), Change in appendicular fat mass (kg), Change in trunk fat mass (kg) and Percentage change in total fat mass (%).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 212 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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