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Growth Hormone Antagonist

Pegvisomant for Insulin Resistance

Phase 2
Recruiting
Led By Rebecca J Brown, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 18-65 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study Summary

This trial is studying if blocking the effects of growth hormone in the body will help people with severe insulin resistance.

Who is the study for?
Adults aged 18-65 with severe insulin resistance due to a variant in the insulin receptor gene or partial lipodystrophy can join. They must have completed puberty, not be on blood thinners, pregnant, or breastfeeding. Participants need to use contraception and cannot have certain medical conditions like significant liver disease.Check my eligibility
What is being tested?
The trial is testing Pegvisomant, a drug that blocks growth hormone effects in those with severe insulin resistance from lipodystrophy syndromes. It involves two hospital stays for tests and daily self-administered shots of Pegvisomant between visits.See study design
What are the potential side effects?
Pegvisomant may cause side effects such as reactions at the injection site, liver issues (elevated liver enzymes), headaches, and potential allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a genetic variant affecting insulin or diagnosed with partial lipodystrophy.
Select...
I am between 18 and 65 years old.
Select...
I have finished growing and gone through puberty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glycerol rate of appearance (Ra) normalized to fat mass, Palmitate Ra normalized to fat mass

Side effects data

From 2017 Phase 4 trial • 44 Patients • NCT01701973
20%
Abdominal cramping and diarrhea
20%
Dizziness and paresthesias during arginine infusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sitagliptin Plus Pegvisomant
Sitagliptin Plus LNMMA
Sitagliptin
Sitagliptin Plus Exendin 9-39

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
open label pegvisomant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegvisomant
2010
Completed Phase 4
~320

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,348 Previous Clinical Trials
4,314,707 Total Patients Enrolled
87 Trials studying Insulin Resistance
13,205 Patients Enrolled for Insulin Resistance
Rebecca J Brown, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
1,530 Total Patients Enrolled
3 Trials studying Insulin Resistance
1,218 Patients Enrolled for Insulin Resistance

Media Library

Pegvisomant (Growth Hormone Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05470504 — Phase 2
Insulin Resistance Research Study Groups: 1
Insulin Resistance Clinical Trial 2023: Pegvisomant Highlights & Side Effects. Trial Name: NCT05470504 — Phase 2
Pegvisomant (Growth Hormone Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470504 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a high incidence of adverse effects for individuals who undergo this treatment?

"Given that this is a Phase 2 trial - meaning while there is some safety data, none exists yet on efficacy - our team has given it a score of 2."

Answered by AI

Are patients of all ages being considered for this experiment?

"The age restriction for this specific trial is that all participants must be aged between 18 and 65."

Answered by AI

What are the prerequisites for taking part in this research?

"The eligibility requirements for this clinical trial include being insulin resistant and aged 18-65. This study needs to enroll 25 patients in total."

Answered by AI

Are people with the required health conditions able to take part in this trial right now?

"According to the listing on clinicaltrials.gov, this study is not recruiting at present. The trial was first posted on November 23rd, 2022 and was last updated a week ago on November 17th, 2022. Although this particular study isn't looking for candidates, there are 196 other studies that are currently recruiting patients."

Answered by AI
~10 spots leftby Jan 2025