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Study of Pegvisomant for Severe Insulin Resistance

This study is looking at how a drug called Pegvisomant might help people with severe insulin resistance. Insulin resistance is a condition where your body doesn't respond well to insulin, which can lead to health problems. This study is for adults aged 18 to 70 who have either a specific change (pathogenic variant) in their insulin receptor gene or a diagnosis of partial lipodystrophy (a rare disorder affecting how your body stores and uses fat). Researchers want to see if Pegvisomant, which blocks the effects of growth hormone, can reduce the breakdown of fat tissue. Success in this study would mean that Pegvisomant reduces the rate at which fat is broken down, measured after one month of treatment. The study plans to enroll 25 participants, and its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved
You would have two hospital stays, each lasting 3 or 4 nights, about one month apart. During each stay, you would have a physical exam, blood tests, and other tests.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements are taken at 1 month after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05470504

Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance

Recruiting
PHASE2Ages 18–70InterventionalTreatment
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~25 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Pegvisomant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glycerol rate of appearance (Ra) normalized to fat mass, Palmitate Ra normalized to fat mass
Measured over 1 month

Conditions

Insulin Receptor Mutation
Partial Lipodystrophy

Explore related trials

Insulin Receptor MutationPartial LipodystrophySevere Insulin Resistance

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

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

Who to contact

Megan S Startzell, R.N.
[email protected]
(301) 402-6371
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Glycerol rate of appearance (Ra) normalized to fat mass, Palmitate Ra normalized to fat mass1 month

    Estimate the magnitude and variability of the effect of pegvisomant, 30 mg subcutaneously once daily for 1 month, on adipose tissue lipolysis rate in subjects with pathogenic variants in the insulin receptor and partial lipodystrophy.