PCOSPhase 4NCT04263415
The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity
A Phase 4 study testing Semaglutide in people with PCOS and Semaglutide, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PCOS, Semaglutide, Taste, Altered
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Nov 2019to 31 Oct 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed written consent
- Diagnosed with PCOS by Rotterdam criteria
- BMI > 30 kg/m2
- Age 18 years-menopause
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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, we 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.
- Conditions
- PCOS, Semaglutide, Taste, Altered, Tongue Tissue Transcriptome, Gastric Emptying, Central Neural Response
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic
semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks
PlaceboOther
once-weekly injection with placebo pen for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| group P | Placebo comparator | once-weekly injection with placebo pen. Receives: Other: Placebo |
| group S | Experimental | Once-weekly application of semaglutide Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test
Measured: 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
Measured: Change in transcriptomic profile from baseline up to the end of 12th week.
Secondary outcomes (5)
Change in neural response to visual food cues and taste task as assessed by functional MRI
Measured: Change in neural response to visual food cues and taste task from baseline up to the end of 12th week.
Change in eating behaviour by using a Slovenian translation of Three-Factor Eating Questionnaire TFEQ-R18.
Measured: Change in eating behaviour from baseline to the end of 12th week of therapy.
Change in body weight measured with body weight scale to the nearest 1 kg
Measured: Change in body weight from baseline to the end of 12th week of therapy.
Change in body fat mass assessed by a Dual Energy X-ray Absorptiometry
Measured: Change in body fat mass from baseline to the end of 12th week of therapy.
The impact of sema on gastric emptying
Measured: Change of gastric emptying from baseline to the end of 12th week of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start2 Nov 2019
- Primary completion8 May 2020
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, single-blind, placebo-controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263415
- Sponsor's protocol ID
- sema in PCOS
- Status last verified
- Sep 2023
- First submitted
- 5 Feb 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensterle M, Ferjan S, Battelino T, Kovac J, Battelino S, Suput D, Vovk A, Janez A. Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial. Trials. 2021 Jul 19;22(1):464. doi: 10.1186/s13063-021-05442-y.
PubMed 34281590
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04263415
- Acronym / sponsor ID
- sema in PCOS
- Conditions
- PCOS, Semaglutide, Taste, Altered, Tongue Tissue Transcriptome, Gastric Emptying, Central Neural Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, we 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized, single-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| group P | Placebo comparator | Other: Placeboonce-weekly injection with placebo pen. |
| group S | Experimental | Drug: SemaglutideOnce-weekly application of semaglutide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed written consent
- Diagnosed with PCOS by Rotterdam criteria
- BMI > 30 kg/m2
- Age 18 years-menopause
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Ozempicsemaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks | Drug | group S |
| Placeboonce-weekly injection with placebo pen for 16 weeks | Other | group P |
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.
5 secondary outcomes
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 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 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.
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.
The impact of sema on gastric emptying
Time frame: Change of gastric emptying from baseline to the end of 12th week of therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 34281590Jensterle M, Ferjan S, Battelino T, Kovac J, Battelino S, Suput D, Vovk A, Janez A. Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial. Trials. 2021 Jul 19;22(1):464. doi: 10.1186/s13063-021-05442-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with PCOS and Semaglutide, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.