Could blocking growth hormone ease severe insulin resistance?
NCT ID NCT05470504
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study tests a drug called pegvisomant in 25 adults with severe insulin resistance caused by lipodystrophy or insulin receptor gene changes. Participants give themselves daily shots for one month and have two hospital stays for tests. The goal is to see if blocking growth hormone can improve how the body handles fat and sugar.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: * Either * Known pathogenic variant in the insulin receptor gene, either dominant negative or recessive, OR * Clinical diagnosis of partial lipodystrophy based on reduction in adipose tissue outside the normal range in selected adipose depots (including, at a minimum, the gluteofemoral depot) with preservation of adipose tissue in other depots. * Male or female, aged 18-70 years. * Completed linear growth and puberty. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Use of niacin or other drugs that directly affect lipolysis within 8 weeks prior to enrollment. * Patients taking anticoagulants (blood thinning medications). * Use of non-steroidal anti-inflammatory medications (e.g., aspirin, ibuprofen) 2 weeks prior to the biopsy date (in patients who choose to undergo biopsy). * Changes in medications for diabetes or dyslipidemia within 2 weeks prior to enrollment. * Pregnancy or lactation. * For females of reproductive potential: inability or unwillingness to use contraception during study participation and for an additional 1 month after the end of pegvisomant administration. * For males of reproductive potential: inability or unwillingness to use condoms or other methods to ensure effective contraception with partner during the study and for an additional 1 month after the end of pegvisomant administration. * Known allergic reactions pegvisomant or any of its components. * Clinically significant liver disease, evidenced by any of the following: * ALT or AST \>3 times the upper limit of normal at screening. * Current known liver disease other than steatohepatitis (e.g., autoimmune or viral hepatitis). * History of cirrhosis * Triglycerides \>1500 mg/dL (non-fasting) or \>1000 mg/dL (fasting) at screening. * In subjects with partial lipodystrophy only, Hemoglobin A1c \>10% at screening. * Any other medical condition or medication that, in the judgement of the investigator, will increase risk to the subject or impede the measurement of study outcomes. * Inability of subject to understand or the unwillingness to sign a written informed consent document.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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