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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 belowSelect...
I have regular menstrual cycles.
Select...
My puberty development was normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
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
3,023 Previous Clinical Trials
13,317,933 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a chronic disease, but it's not thyroid or my thyroid disease is well controlled.I have not used contraceptive pills, patches, or rings in the last 4 weeks.You currently use illegal drugs.You have a healthy weight, with a BMI between 18.5-25.I haven't taken any medication recently that affects metabolism or reproduction, except for levothyroxine or allergy meds.I have regular menstrual cycles.I am over 18 years old.My puberty development was normal.You had a serious reaction to a medication before that required immediate medical attention.A close family member has diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Kisspeptin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.