DelfaGLP-1 Atlas

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CompletedPhase 4

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

The Effects of Semaglutide on Modulation of Taste Sensitivity, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Responses in Women With PCOS and Obesity: a Randomized, Single-blind, Placebo-controlled Clinical Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

30

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥30•Female

Primary endpoints

•Effect of semaglutide on taste perception as change in taste sensitivity•CO-PRIMARY END-POINT

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04263415
Org study IDsema in PCOS

Timeline

Milestones

Study start2019-11-02actual
Study first posted2020-02-10actual
Primary completion2020-05-08actual
Study completion2021-10-31actual
Last update posted2023-09-08actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Informed written consent
•Diagnosed with PCOS by Rotterdam criteria
•BMI > 30 kg/m2
•Age 18 years-menopause

Exclusion criteria

•Severe psychiatric disease including schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
•Current history of neurological disease including traumatic brain surgery
•Current history of diagnosis of type I or type II diabetes or plasma haemoglobin A1c 6.5% at inclusion
•Impaired hepatic function (liver transaminases>3 times upper normal limit)
•Impaired renal function (estimated glomerular filtration rate (eGFR)< 50 ml/min
•Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase >2 times upper limit)
•Bleeding disorders
•Women who are pregnant, breast feeding or have intention of becoming pregnant within the next 9 months
•Women who are planning any operation within the next 6 months
•History of medullary thyroid carcinoma (MTC) and/or family history with MTC and/or multiple endocrine neoplasia syndrome type 2
•Cardiac problems defined as decompensated heart failure (New York Herat Association functional class III or IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
•Uncontrolled hypertension (systolic blood pressure > 180 mmHg, diastolic blood pressure > 110 mmHg
•Receiving GLP-1 agonist within the last 12 months
•Use of any weight-lowering pharmacotherapy within the preceding 3 months
•Contraindication for MR scanning (magnetic implants, pacemaker, claustrophobia etc)
•Any condition that the investigator feels would interfere with trial participation

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
3
Weight & body composition
2
Patient-reported / QoL
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in body weight measured with body weight scale to the nearest 1 kg

Time frame:Change in body weight from baseline to the end of 12th week of therapy.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body fat mass assessed by a Dual Energy X-ray Absorptiometry

Time frame:Change in body fat mass from baseline to the end of 12th week of therapy.

Total fat mass

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in eating behaviour by using a Slovenian translation of Three-Factor Eating Questionnaire TFEQ-R18.

Time frame:Change in eating behaviour from baseline to the end of 12th week of therapy.

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/protocol endpoint

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.

change from baseline, improvement

Secondary/protocol endpoint

Change in neural response to visual food cues and taste task as assessed by functional MRI

Time frame:Change in neural response to visual food cues and taste task from baseline up to the end of 12th week.

change from baseline, descriptive

Secondary/protocol endpoint

The impact of sema on gastric emptying

Time frame:Change of gastric emptying from baseline to the end of 12th week of therapy.

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

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.

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.