Testing the Efficacy, Safety, and PK of 20E in Patients With Obesity Who Are Starting Treatment With the GLP-1 Agonist Semaglutide for Weight Loss.

What Was Tested

This registered phase 2 trial tested Semaglutide for fat loss, obesity & body recomposition.

After the end of the study (after last patient did the last visit at the clinic), researchers will compare the BIO101-treated arm to the placebo control arm to see if the candidate drug has an effect on muscle strength, physical function, lean body mass and health related quality of life compared to placebo.

It had two arms (groups): BIO101 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 164 planned participants were the target.

It was open to people of any sex aged from 18 years up to 84 years.

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

Examples of who could join: Willing to participate and able to sign an ICF. BMI ≥30 or BMI ≥27 with one or more weight-associated co-morbidities (e.g. hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease). Start of treatment with semaglutide for weight loss at Day 3 after the start of the study treatment. Willing to maintain sufficient exercise, i.e. at least 150 minutes per week moderate-vigorous exercise. Body weight stable (within a 5 kg range) in the 3 months prior to enrolment.

The full record lists 8 inclusion and 28 exclusion criteria; among the exclusions: participant not able to take medications by mouth (as capsules); any known hypersensitivity to any of the active substances (20e), and its excipients (the study medication) and the active substance and the excipients of semaglutide; history or present cholelithiasis or cholecystectomy from medical history or sludge or stones observed on gallbladder ultrasound or any other method.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Neither the fat loss, obesity & body recomposition participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-07 with completion listed for 2027-06.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in the knee extension strength at 21 weeks (time frame: Baseline and 21 weeks).

It also tracked 18 secondary outcomes, for example Change from baseline in the knee flexion strength at 21 weeks, Change from baseline in handgrip strength at 21 weeks, Change from baseline in the 6-minute walking distance test (6MWD) at 21 weeks, Change from baseline in Stair Climb Power Test (SCPT) at 21 weeks, Change from baseline of five times Sit to Stand Test (5xSST) at 21 weeks and Change from baseline in appendicular and total lean body mass and fat mass at 21 weeks.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 164 people with fat loss, obesity & body recomposition.

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, Fat loss, obesity & body recomposition research.