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Leptin Analog

Metreleptin for Lipodystrophy

Phase 2
Waitlist Available
Led By Rebecca J Brown, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented metabolic benefit from prior or current metreleptin treatment, defined as one or more of the following: TG reduction greater than or equal to 30%, HbA1c reduction greater than or equal to 1%, Decrease in insulin requirements greater than or equal to 40%, Decrease in episodes of pancreatitis, Improvement in steatohepatitis, Withdrawal of metreleptin led to marked worsening of metabolic parameters
Partial lipodystrophy (either genetic or acquired)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6-12 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of metreleptin, a drug that has been shown to improve health in people with partial lipodystrophy. Eligible participants will receive free metreleptin and travel assistance to NIH for regular checkups.

Who is the study for?
This trial is for people over 6 months old with partial lipodystrophy who've seen health improvements from previous metreleptin treatment in NIH studies but can't access the drug elsewhere. They must have experienced significant benefits like reduced blood fats or better diabetes control and commit to regular local doctor visits.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of metreleptin, a medication previously shown to help with insulin resistance and high blood fat levels caused by partial lipodystrophy. Participants will receive metreleptin for daily injections, undergo various health checks, scans, and possibly liver biopsies.See study design
What are the potential side effects?
Potential side effects of metreleptin may include reactions at the injection site, low blood sugar if taking other diabetes medications, headaches, weight loss, abdominal pain, or allergic reactions in those sensitive to E. coli-derived proteins.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have seen improvements in my health from metreleptin treatment.
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I have partial lipodystrophy.
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I am at least 6 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum hemoglobin A1C
Serum triglycerides

Side effects data

From 2015 Phase 2 trial • 103 Patients • NCT00025883
15%
Musculoskeletal pain
12%
Weight loss
10%
Hypoglycemia
9%
Nausea
8%
Abdominal pain
7%
Infection
7%
Fatigue
6%
tumor, benign
6%
Anemia
6%
Anxiety
5%
Diarrhea
5%
Insomnia
5%
Constipation
4%
Depression
4%
Headache
4%
Joins pain
4%
Decreased appetite
4%
Iron deficiency
2%
Pneumonia
2%
Exacerbations of heart failure
1%
Group B streptococcus bacteremia
1%
Abdominal pain requiring hospitalization
1%
Osteomyelitis
1%
Acute exacerbation of pancreatitis
1%
Ovarian cyst requiring bilateral oophorectomy and total abdominal hysterectomy
1%
Cellulitis
1%
Miscarriage
1%
Severe acute bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metreleptin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leptin therapyExperimental Treatment1 Intervention
leptin administered via SC injections BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metreleptin
2001
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,338 Previous Clinical Trials
4,314,169 Total Patients Enrolled
20 Trials studying Lipodystrophy
2,095 Patients Enrolled for Lipodystrophy
Rebecca J Brown, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
1,525 Total Patients Enrolled
6 Trials studying Lipodystrophy
189 Patients Enrolled for Lipodystrophy

Media Library

Metreleptin (Leptin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT02262806 — Phase 2
Lipodystrophy Research Study Groups: Leptin therapy
Lipodystrophy Clinical Trial 2023: Metreleptin Highlights & Side Effects. Trial Name: NCT02262806 — Phase 2
Metreleptin (Leptin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02262806 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this intervention been approved by the regulating body?

"Given the Phase 2 status of this treatment, there is limited clinical evidence supporting its safety but no data to back up efficacy. Thus, our team at Power assigned a rating of two out of three."

Answered by AI

Is this trial actively seeking out new participants?

"Details found on clinicaltrials.gov reveal that, since the original posting of this study on October 14th 2014 and its most recent update on September 9th 2022, it is no longer recruiting patients. However, presently there are 246 other trials looking for enrollees."

Answered by AI

What is the scope of participation in this research project?

"This trial is no longer recruiting patients. It was initially posted on October 14th 2014 and last updated September 9th 2022. However, there are currently 241 studies focusing on lipidemia which are still open to participants, as well as 5 trials offering this particular treatment with positions available."

Answered by AI

Is there any precedent for this treatment, as demonstrated by prior research?

"At the present moment, 5 studies are underway for this treatment with 2 of them being in Phase 3. Columbus Ohio is hosting most of these trials while 14 other sites across America offer access to it as well."

Answered by AI
Recent research and studies
~4 spots leftby Jul 2025