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Hormone Therapy

Kisspeptin for Metabolic Diseases

Phase 1
Waitlist Available
Led By Margaret Lippincott, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
regular menstrual cycles
normal pubertal development
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours

Summary

This trial studies how kisspeptin, a natural protein, affects metabolism. Participants will receive kisspeptin and then take a sugar test. Researchers aim to see if kisspeptin changes how the body handles sugar.

Who is the study for?
This trial is for adults over 18 with normal blood pressure, kidney and liver function, stable weight, no diabetes in close family, and women must not be pregnant. Participants should have a healthy BMI (18.5-25), regular menstrual cycles if female, and controlled thyroid disease is okay.
What is being tested?
The study tests how kisspeptin affects the body's response to sugar by using an oral glucose tolerance test compared to a placebo. The goal is to understand kisspeptin's role in metabolism.
What are the potential side effects?
Potential side effects are not detailed but may include reactions similar to other hormonal treatments such as changes in appetite, mood swings, or injection site discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have regular menstrual cycles.
Select...
My puberty development was normal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average Difference in Oral glucose Sensitivity Index (Kisspeptin-Placebo)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KisspeptinExperimental Treatment2 Interventions
• Intravenous administration of kisspeptin 112-121 x 16 hours
Group II: PlaceboPlacebo Group2 Interventions
• Intravenous administration of placebo x 16 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Glucose Tolerance Test
2017
Completed Phase 4
~840
Kisspeptin
2021
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,309,295 Total Patients Enrolled
6 Trials studying Metabolic Diseases
442 Patients Enrolled for Metabolic Diseases
Margaret Lippincott, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Kisspeptin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04958109 — Phase 1
Metabolic Diseases Research Study Groups: Kisspeptin, Placebo
Metabolic Diseases Clinical Trial 2023: Kisspeptin Highlights & Side Effects. Trial Name: NCT04958109 — Phase 1
Kisspeptin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958109 — Phase 1
~4 spots leftby Nov 2025
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