HealthyPhase 4NCT04865744
The Effect of Semaglutide on Pituitary Function
A Phase 4 study testing Semaglutide 7 MG Oral Tablet and Semaglutide 14 MG Oral Tablet in people with Healthy, run by University of Tartu at 1 site in Estonia.
Trial summary
The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Semaglutide 7 MG Oral Tablet and Semaglutide 14 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEstonia
- Study dates
- 19 May 2021to 30 Sep 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years
- The body weight >65 kg
Who cannot join
- presence of chronic illness
- the daily use of medications
- pregnancy
- lactation.
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.
Read the detailed description
The randomized blinded placebo-controlled clinical trial is conducted on 10 healthy volunteers.
5 study subjects receive once 7 mg of oral semaglutide and once placebo. 5 study subjects receive once 14 mg of oral semaglutide and once placebo. The study group and order of administration of study medication are decided on randomization. The placebo and oral semaglutide are administered at least 4 weeks apart.
Blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration).
The primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.
- Conditions
- Healthy
- Being tested
- Semaglutide 7 MG Oral Tablet, Placebo, Semaglutide 14 MG Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 7 MG Oral TabletDrug
Also called Rybelsus 7 mg
Semaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water.
PlaceboDrug
Placebo tablet is taken after an overnight fast with up to120 ml of water.
Semaglutide 14 MG Oral TabletDrug
Also called Rybelsus 14 mg
Semaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water.
| Study group | Role | What they receive |
|---|---|---|
| Oral semaglutide 7 mg | Active comparator | The semaglutide 7 mg tablet taken orally with upto120 ml of water. Receives: Drug: Semaglutide 7 MG Oral Tablet |
| Placebo | Placebo comparator | The placebo tablet taken orally with 120 ml of water. Receives: Drug: Placebo |
| Oral semaglutide 14 mg | Active comparator | The semaglutide 14 mg tablet taken with upto 120 ml of water. Receives: Drug: Semaglutide 14 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone peak
Maximum concentration measured after study medication administration.
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Secondary outcomes (6)
Cortisol peak
Maximum concentration measured after study medication administration.
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Adrenocorticotropin (ACTH) peak
Maximum concentration measured after study medication administration.
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Aldosterone peak
Maximum concentration measured after study medication administration.
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Glucose nadir
Lowest glucose concentration measured after study medication administration
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
C-peptide peak
Maximum concentration measured after study medication administration.
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Copeptin peak
Maximum concentration measured after study medication administration
Measured: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start19 May 2021
- Primary completion23 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Blinded Randomised Single-group Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vallo Volke, University of Tartu
- Investigators
- Vallo Volke, MD, PhD, Principal investigator, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865744
- Sponsor's protocol ID
- Sema21
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2021
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semaglutide on Pituitary Function
- ClinicalTrials.gov ID
- NCT04865744
- Acronym / sponsor ID
- Sema21
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 29 Apr 2021 (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 primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.
Detailed description
The randomized blinded placebo-controlled clinical trial is conducted on 10 healthy volunteers.
5 study subjects receive once 7 mg of oral semaglutide and once placebo. 5 study subjects receive once 14 mg of oral semaglutide and once placebo. The study group and order of administration of study medication are decided on randomization. The placebo and oral semaglutide are administered at least 4 weeks apart.
Blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration).
The primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Blinded Randomised Single-group Crossover
| Arm | Type | Receives |
|---|---|---|
| Oral semaglutide 7 mg | Active comparator | Drug: Semaglutide 7 MG Oral TabletThe semaglutide 7 mg tablet taken orally with upto120 ml of water. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo tablet taken orally with 120 ml of water. |
| Oral semaglutide 14 mg | Active comparator | Drug: Semaglutide 14 MG Oral TabletThe semaglutide 14 mg tablet taken with upto 120 ml of water. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50 years
- The body weight >65 kg
Key exclusion criteria (4 listed)
- presence of chronic illness
- the daily use of medications
- pregnancy
- lactation.
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 |
|---|---|---|
| Semaglutide 7 MG Oral TabletAlso: Rybelsus 7 mgSemaglutide 7 mg oral tablet taken after an overnight fast with up to 120 ml of water. | Drug | Oral semaglutide 7 mg |
| PlaceboPlacebo tablet is taken after an overnight fast with up to120 ml of water. | Drug | Placebo |
| Semaglutide 14 MG Oral TabletAlso: Rybelsus 14 mgSemaglutide 14 mg oral tablet taken after an overnight fast with up to 120 ml water. | Drug | Oral semaglutide 14 mg |
Primary outcome
Growth hormone peak
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Maximum concentration measured after study medication administration.
6 secondary outcomes
Cortisol peak
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Adrenocorticotropin (ACTH) peak
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Aldosterone peak
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Glucose nadir
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
C-peptide peak
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
Copeptin peak
Time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration
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 22 Feb 2023.
- 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.
Vallo Volke, MD, PhD principal investigator
University of Tartu
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 7 MG Oral Tablet and Semaglutide 14 MG Oral Tablet in people with Healthy, run by University of Tartu at 1 site in Estonia.
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 2 inclusion and 4 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 22 Feb 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 Estonia. 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?
Growth hormone peak (time frame: 60, 90, 120, 150, 180 and 240 minutes after study medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2023.