Mass General - Division of Clinical Research

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

Purpose

This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.

Condition

Partial Lipodystrophy

Eligibility

Eligible Ages: Over 12 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Diagnosis of Familial Partial Lipodystrophy (FPLD) - Subjects with poor metabolic control defined as: HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3) - Patients should be receiving optimized stable therapy

Exclusion Criteria

Previous treatment with metreleptin - Leptin levels >20.0 ng/mL - Acquired or radiation induced partial lipodystrophy (APL) Other protocol defined inclusion/exclusion criteria apply

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator metreleptin	Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake	Drug: metreleptin Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency
Placebo Comparator placebo	Placebo for daily injection is a sterile, white, solid lyophilised cake	Drug: Placebo Placebo

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

Contact:
Lindsay Fourman

More Details

Status: Recruiting
Sponsor: Amryt Pharma

Study Contact

Janet Boylan
+3905212791
clinicaltrials_info@chiesi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.