Metabolic DiseasesPhase 1NCT04958109
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
A Phase 1 study testing Oral Glucose Tolerance Test and Kisspeptin in people with Metabolic Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Oral Glucose Tolerance Test and Kisspeptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2021to 31 Oct 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- History:
- over the age of 18,
- normal pubertal development
- stable weight for previous three months,
- normal body mass index (BMI between 18.5-25)
- regular menstrual cycles
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- Physical examination:
- systolic BP < 140 mm Hg, diastolic < 90 mm Hg
- Laboratory studies: (per Massachusetts General Hospital reference ranges)
- normal hemoglobin
- hemoglobin A1C < 6.5%
- blood urea nitrogen, creatinine not elevated
- aspartate aminotransferase, alanine aminotransferase < 3x upper limit of normal
Who cannot join
- active illicit drug use,
- history of a medication reaction requiring emergency medical care,
- difficulty with blood draws.
- history of chronic disease, except well controlled thyroid disease,
- recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
- history of diabetes in a first degree relative,
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- use of contraceptive pills, patches or vaginal rings within last 4 weeks.
- hyperlipidemia by fasting lipid panel
- positive serum pregnancy test (for all women)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test
Read the detailed description
Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.
Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
- During the inpatient study, the subjects will
- Undergo a 16-hour kisspeptin infusion
- Undergo an oral glucose tolerance test
- Conditions
- Metabolic Diseases
- Being tested
- Oral Glucose Tolerance Test, Kisspeptin, Placebo
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestDiagnostic test
Administration of a 75 gm oral glucose tolerance test
KisspeptinDrug
Intravenous administration of kisspeptin 112-121 x 16 hours
PlaceboDrug
Intravenous administration of Placebo 16 hours
| Study group | Role | What they receive |
|---|---|---|
| Kisspeptin | Experimental | • Intravenous administration of kisspeptin 112-121 x 16 hours Receives: Diagnostic Test: Oral Glucose Tolerance Test; Drug: Kisspeptin |
| Placebo | Placebo comparator | • Intravenous administration of placebo x 16 hours Receives: Diagnostic Test: Oral Glucose Tolerance Test; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start28 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Stephanie B. Seminara, MD, Massachusetts General Hospital
- Investigators
- Margaret Lippincott, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958109
- Sponsor's protocol ID
- 267339
- Other IDs
- 5K23HD097296
- Status last verified
- Nov 2024
- First submitted
- 1 Jul 2021
- Last updated
- 6 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
- ClinicalTrials.gov ID
- NCT04958109
- Acronym / sponsor ID
- 267339
- Conditions
- Metabolic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test
Detailed description
Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.
Delivery of Interventions:
- Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
- During the inpatient study, the subjects will
- Undergo a 16-hour kisspeptin infusion
- Undergo an oral glucose tolerance test
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kisspeptin | Experimental | Diagnostic Test: Oral Glucose Tolerance Test, Drug: Kisspeptin• Intravenous administration of kisspeptin 112-121 x 16 hours |
| Placebo | Placebo comparator | Diagnostic Test: Oral Glucose Tolerance Test, Drug: Placebo• Intravenous administration of placebo x 16 hours |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- over the age of 18,
- normal pubertal development
- stable weight for previous three months,
- normal body mass index (BMI between 18.5-25)
- regular menstrual cycles
Key exclusion criteria (9 listed)
- active illicit drug use,
- history of a medication reaction requiring emergency medical care,
- difficulty with blood draws.
- history of chronic disease, except well controlled thyroid disease,
- recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
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 |
|---|---|---|
| Oral Glucose Tolerance TestAdministration of a 75 gm oral glucose tolerance test | Diagnostic test | Kisspeptin, Placebo |
| KisspeptinIntravenous administration of kisspeptin 112-121 x 16 hours | Drug | Kisspeptin |
| PlaceboIntravenous administration of Placebo 16 hours | Drug | Placebo |
Primary outcome
Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
Time frame: 3 hours
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Margaret Lippincott, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral Glucose Tolerance Test and Kisspeptin in people with Metabolic Diseases, run by Massachusetts General Hospital at 1 site in United States.
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 13 inclusion and 9 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 6 Mar 2026. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oral Glucose Sensitivity Index (Kisspeptin-Placebo) (time frame: 3 hours). 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 6 Mar 2026.