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Growth Hormone Receptor Antagonist

Pegvisomant for Acromegaly

N/A
Waitlist Available
Led By Shlomo Melmed, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

Acromegaly is a disease of the pituitary gland that involves overproduction of growth hormone. Pegvisomant works by blocking binding of GH to receptors found in tissues throughout the body. Human studies have evaluated pegvisomant action by measuring reduction of IGF-I levels in the blood. However, no studies have evaluated the effects of blocking GH receptors in tissues. In this study, we will study tissue biomarkers for pegvisomant action in GH and IGF-I dependent signaling pathways in colon tissue of patients with acromegaly treated with pegvisomant.

Eligible Conditions
  • Acromegaly

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of Pegvisomant on Colon Tissue p53 Expression

Side effects data

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PegvisomantExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegvisomant
FDA approved

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
511 Previous Clinical Trials
163,296 Total Patients Enrolled
8 Trials studying Acromegaly
355 Patients Enrolled for Acromegaly
Shlomo Melmed, MDPrincipal InvestigatorCedars-Sinai Medical Center
7 Previous Clinical Trials
1,543 Total Patients Enrolled
2 Trials studying Acromegaly
231 Patients Enrolled for Acromegaly
~1 spots leftby Nov 2025
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