CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
pegvisomantdrug
Likely dose
pegvisomant 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02023918
NCT02023918Phase 2Completed

Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes

University of California, San Francisco·interventional·Posted Dec 30, 2013·Updated Apr 24, 2017

In Brief

A Phase 2 clinical trial evaluating pegvisomant for Diabetes and 2 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 30, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.5 years ago

Interventions

pegvisomantdrug

Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.