Study to Evaluate the Safety & Efficacy of Daily Subcutaneous Metreleptin

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05470504` - Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance	Phase 2
Recruiting	`NCT02325674` - MEASuRE: Metreleptin Effectiveness And Safety Registry
Completed	`NCT00896298` - Trial of Leptin Replacement Therapy in Patients With Lipodystrophy	Phase 2/Phase 3

See also

Status

Clinical Trial

Phase

Recruiting

NCT05470504 - Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance

Phase 2

Recruiting

NCT02325674 - MEASuRE: Metreleptin Effectiveness And Safety Registry

Completed

NCT00896298 - Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

Phase 2/Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05164341
Study type	Interventional
Source	Amryt Pharma
Contact	Janet Boylan
Phone	+35315180200
Email	medinfo@amrytpharma.com
Status	Recruiting
Phase	Phase 3
Start date	December 17, 2021
Completion date	January 31, 2026

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL — METRE-PL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms