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Trial · Interventional

CompletedPhase 1Results postedRegistry data

Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

NCTNCT04958109 (opens ClinicalTrials.gov in a new tab)Other id267339Other id5K23HD097296
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Kisspeptin-10, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 1
Enrollment
16 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
28 Oct 2021
Primary completion
31 Oct 2022
Completion
31 Oct 2022
First posted
12 Jul 2021
Last update posted
6 Mar 2026
Conditions
Metabolic Diseases

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 1

    Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test

    NCT04958109

    28 Oct 2021 to 31 Oct 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an oral glucose tolerance test

Interventions

  • Oral Glucose Tolerance TestDiagnostic test
  • KisspeptinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Kisspeptin

    • Intravenous administration of kisspeptin 112-121 x 16 hours

  • Placebo comparator

    Placebo

    • Intravenous administration of placebo x 16 hours

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Oral Glucose Sensitivity Index (Kisspeptin-Placebo)

    Time frame · 3 hours

    Registry description

    Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 hours

Oral Glucose Sensitivity Index (Kisspeptin-Placebo)

GroupValue (ml min-1m-2)Spread
Kisspeptin51770
Placebo52182

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
KisspeptinOral Glucose Tolerance Test(OGTT): Administration of a 75 gm oral glucose tolerance test Kisspeptin: Intravenous administration of kisspeptin 112-121 x 16 hours, then at hour 12 OGTT0 / 90 / 96 / 9
PlaceboOral Glucose Tolerance Test (OGTT): Administration of a 75 gm oral glucose tolerance test Placebo: Intravenous administration of Placebo 16 hours, then at hour 12 OGTT0 / 90 / 96 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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 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 Exclusion Criteria: * 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, * use of contraceptive pills, patches or vaginal rings within last 4 weeks. * hyperlipidemia by fasting lipid panel * positive serum pregnancy test (for all women)

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