MedTrace Logo

Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance

NCT05470504 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-12

No results posted yet for this study

Summary

Background:

Lipodystrophy (LD) syndromes are a group of rare disorders that affect how a person s body can store and use fat tissue. Many people with LDs become severely insulin resistant. Some people are insulin resistant because of a variant in the insulin receptor gene. Insulin resistance causes many health problems.

Objective:

To learn if blocking the effects of growth hormone in the body will help people with severe insulin resistance.

Eligibility:

Adults aged 18 to 65 years with either a known variant in the insulin receptor gene or with a diagnosis of partial LD.

Design:

Participants will have 2 hospital stays, about 1 month apart. Each stay will be 3 or 4 nights.

During each hospital stay, participants will have many tests. They will have a physical exam with blood tests. They will have all of their urine collected for a 24-hour period. They will have scans to measure their muscle, bone, and fat tissues. They will have tests to measure metabolism and insulin sensitivity. They may have an optional biopsy of fat tissue.

During the first hospital visit, participants will learn how to give themselves shots of a drug (pegvisomant) that blocks growth hormone. The drug is injected under the skin. Participants will continue to give themselves these shots once a day at home.

After the first hospital visit, participants will talk on the phone with members of the study team once each week. After 2 weeks they will have blood drawn for tests.

Participants will stop the shots after the second hospital visit.

Conditions

  • Insulin Receptor Mutation
  • Partial Lipodystrophy

Interventions

DRUG

Pegvisomant

30 mg subcutaneously every day for 4 weeks.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Rebecca J Brown, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2028-01-30
Completion
2028-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05470504 on ClinicalTrials.gov