The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity

What Was Tested

This registered phase 4 trial tested Semaglutide for pcos.

The purpose of the study is to explore the effects of GLP-1 receptor agonist (GLP-1 RA) semaglutide on modulation of taste sensitivity, tongue tissue transcriptome, modulation of neural response in central reward processing regions and gastric emptying rate.

In addition, the researchers aim to investigate the associations between semaglutide induced modulation of taste sensitivity, neural responses and gastric emptying with changes in body mass, eating- behavioural pattern, food perception and food intake.

It had two arms (groups): group P (placebo comparator) and group S (experimental).

Once-weekly injection with placebo pen.

Once-weekly application of semaglutide.

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Informed written consent. Diagnosed with PCOS by Rotterdam criteria. BMI \> 30 kg/m2. Age 18 years-menopause.

The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: severe psychiatric disease including schizophrenia, paranoid psychosis, bipolar disorder or mental retardation; current history of neurological disease including traumatic brain surgery; impaired hepatic function (liver transaminases\>3 times upper normal limit).

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant.

It started in 2019-11-02 with completion listed for 2020-05-08.

It ran at 1 site in Slovenia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test (time frame: Changes in taste perception from baseline up to the end of 12th week). CO-PRIMARY END-POINT : to investigate alteration of transcriptomic profile of human tongue tissue as changes in expression level from baseline to follow up after 12 weeks of treatment, measured by RNA sequencing (time frame: Change in transcriptomic profile from baseline up to the end of 12th week).

It also tracked 5 secondary outcomes, for example Change in neural response to visual food cues and taste task as assessed by functional MRI, Change in eating behaviour by using a Slovenian translation of Three-Factor Eating Questionnaire TFEQ-R18, Change in body weight measured with body weight scale to the nearest 1 kg, Change in body fat mass assessed by a Dual Energy X-ray Absorptiometry and The impact of sema on gastric emptying.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 30 people with pcos.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, PCOS research.