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NCT05470504 · ClinicalTrials.gov registry record · Phase 2
Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance
A Phase 2 study of Partial Lipodystrophy and Insulin Receptor Mutation, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05470504: Recruiting Phase 2 study of Partial Lipodystrophy and Insulin Receptor Mutation, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT05470504 is a Phase 2 study of Partial Lipodystrophy and Insulin Receptor Mutation that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05470504, a Phase 2 study of Partial Lipodystrophy and Insulin Receptor Mutation, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Pegvisomant
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 2 |
What NCT05470504 shows while recruiting
NCT05470504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Partial Lipodystrophy appearing as the primary indexed condition, and to 1 intervention - of which Pegvisomant is the first listed.
NCT05470504 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05470504 about?
NCT05470504 is a clinical study titled "Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance". 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...
What is the current status of trial NCT05470504?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2023-01-23. Estimated completion is 2028-01-31.
What conditions does trial NCT05470504 study?
This clinical trial studies the following conditions: Partial Lipodystrophy, Insulin Receptor Mutation.
What interventions are being tested in trial NCT05470504?
The interventions under investigation include: Pegvisomant (DRUG).
Who is sponsoring clinical trial NCT05470504?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05470504 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05470504's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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