Recruiting

Metreleptin

Sponsor:

Chiesi Farmaceutici S.p.A.

Code:

NCT02325674

Conditions

Generalised Lipodystrophy

Partial Lipodystrophy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Metreleptin

Study Details

Brief summary:

The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.

Conditions

Generalised Lipodystrophy

Partial Lipodystrophy

Study ID

NCT02325674

Start date

Oct 11, 2016

Status verified date

Jul, 2026

Completion date

Oct 31, 2031

Anticipated

Primary completion date

Oct 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients treated with metreleptin through commercial supply at the time or before enrolment into registry
  • Patients who provide a written consent
  • Patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply

Exclusion Criteria:

• Patients currently treated with an investigational agent as part of a clinical trial

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Metreleptin

Metreleptin new-users

Metreleptin prevalent users

Interventions

Metreleptin

Primary outcome measure

  • The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practice [ Time Frame: Adverse events will be collected from first dose to last visit - min. 10 years. For Prevalent Users: Serious adverse events will be collected from 6 months prior to enrolment to last visit - min. 10 years. ]

Central Contacts and Locations

Central contacts

Lori Hartnett

+3905212791clinicaltrials_info@chiesi.com

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Barbara Burton, MD

University of Kansas Medical Center Research Institute, Inc.

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Patrick Moriarty, MD

Nih/Niddk/Deob

Recruiting

Bethesda, Maryland, United States, 20892

Principal Investigator:

Marissa Lightbourne, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Elif Oral, MD

Childrens Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Vinood Misra, MD

Endocrinology Research Associates

Recruiting

Columbus, Ohio, United States, 43201

Principal Investigator:

Elena Christofides, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Shana McCormack, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Abhimanyu Garg, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Principal Investigator:

Helen Dichek, MD

More Information

Sponsor

Chiesi Farmaceutici S.p.A.

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Lipodystrophy
  • Metreleptin Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Chiesi Farmaceutici S.p.A. on 2026-07-16.