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No longer availableNCT00677313Updated Aug 21, 2026

Expanded Access for Metreleptin for the Treatment of Diabetes Mellitus and/or Hypertriglyceridemia Associated With Lipodystrophy

An expanded access record providing metreleptin, sponsored by Bristol-Myers Squibb. No longer available. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Bristol-Myers Squibb · Expanded access

Study type
Expanded access
Access type
Individual patients
01

Study summary

This is an expanded access designed to provide metreleptin for the treatment of diabetes mellitus and/or hypertriglyceridemia associated with lipodystrophy.

02

Conditions studied

Keywords

  • metreleptin
  • leptin
  • Amylin
  • diabetes mellitus
  • hypertriglyceridemia
  • lipodystrophy
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

Browse Diabetes Mellitus studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.

Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

Exclusion criteria

Exclusion Criteria:

-

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

06

Where to request access

No study locations are listed for this record.

07

References and documents

Publications

  • Meral R, Malandrino N, Walter M, Neidert AH, Muniyappa R, Oral EA, Brown RJ. Endogenous Leptin Concentrations Poorly Predict Metreleptin Response in Patients With Partial Lipodystrophy. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1739-e1751. doi: 10.1210/clinem/dgab760. PubMed 34677608 ↗
  • Ajluni N, Dar M, Xu J, Neidert AH, Oral EA. Efficacy and Safety of Metreleptin in Patients with Partial Lipodystrophy: Lessons from an Expanded Access Program. J Diabetes Metab. 2016 Mar;7(3):659. doi: 10.4172/2155-6156.1000659. Epub 2016 Mar 23. PubMed 27642538 ↗
  • Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2. PubMed 26589105 ↗
  • Safar Zadeh E, Lungu AO, Cochran EK, Brown RJ, Ghany MG, Heller T, Kleiner DE, Gorden P. The liver diseases of lipodystrophy: the long-term effect of leptin treatment. J Hepatol. 2013 Jul;59(1):131-7. doi: 10.1016/j.jhep.2013.02.007. Epub 2013 Feb 21. PubMed 23439261 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00677313
Responsible party
Sponsor
First posted
May 14, 2008
Last update
Aug 21, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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