Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp

NCT05456854 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 267335
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (2)

• First Phase Insulin Secretion

  Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms

  10 minutes

• Second Phase Insulin Secretion

  Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo Arms

  2 hours

Study Arms (2)

Kisspeptin

EXPERIMENTAL

Intravenous administration of kisspeptin 112-121 x 16 hours

Diagnostic Test: Hyperglycemic Clamp; Drug: Kisspeptin-10

Placebo

PLACEBO COMPARATOR

Intravenous administration of placebo x 16 hours

Diagnostic Test: Hyperglycemic Clamp; Drug: Placebo

Interventions

Hyperglycemic Clamp DIAGNOSTIC_TEST

Administration of a hyperglycemic clamp

Kisspeptin; Placebo

Kisspeptin-10 DRUG

Administration of kisspeptin-10 \* 16 hr

Kisspeptin

Placebo DRUG

Administration of placebo \*16 hr

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• active illicit drug use,
• history of a medication reaction requiring emergency medical care,
• difficulty with blood draws.
• history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
• history of chronic disease that has required hospitalization
• recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
• history of diabetes in a first degree relative
• hyperlipidemia by fasting lipid panel

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

KISS1 protein, human

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Margaret Lippincott

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 13, 2022
• Study Start: June 3, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)