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Leptin Analog

Metreleptin for Generalized Lipodystrophy

Phase 3

Recruiting

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

Age greater than or equal to 6 months

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 in people with generalized lipodystrophy.

Who is the study for?

This trial is for people aged 6 months and older with generalized lipodystrophy who have used metreleptin in NIH studies but can't get it where they live. It's not for those with current substance abuse, increased risk from other conditions or medications, sensitivity to E. coli proteins, HIV, or if they can access metreleptin locally.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of metreleptin in treating complications of generalized lipodystrophy like diabetes. Participants will receive regular supplies of the drug for daily injections and undergo various health checks including blood tests and scans at NIH.See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to daily injections of metreleptin as well as potential discomfort from frequent health monitoring procedures such as blood draws and biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at least 6 months old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6-12 months

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

Glycosylated hemoglobin A

Serum triglycerides

Secondary outcome measures

Bone mineral density & metabolism

Ectopic lipid & body composition

Pituitary & Reproductive Function

+1 more

Side effects data

From 2015 Phase 2 trial • 103 Patients • NCT00025883

15%

Musculoskeletal pain

12%

Weight loss

10%

Hypoglycemia

Nausea

Abdominal pain

Infection

Fatigue

tumor, benign

Anemia

Anxiety

Diarrhea

Insomnia

Constipation

Depression

Headache

Joins pain

Decreased appetite

Iron deficiency

Pneumonia

Exacerbations of heart failure

Group B streptococcus bacteremia

Abdominal pain requiring hospitalization

Osteomyelitis

Acute exacerbation of pancreatitis

Ovarian cyst requiring bilateral oophorectomy and total abdominal hysterectomy

Cellulitis

Miscarriage

Severe acute bronchitis

100%

80%

60%

40%

20%

Study treatment Arm

Metreleptin

Trial Design

1Treatment groups

Experimental Treatment

Group I: Leptin study drugExperimental Treatment1 Intervention

Administration of study drug SQ BID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metreleptin

2001

Completed Phase 2

~170

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,315,465 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: NCT02262832 — Phase 3

Lipodystrophy Research Study Groups: Leptin study drug

Lipodystrophy Clinical Trial 2023: Metreleptin Highlights & Side Effects. Trial Name: NCT02262832 — Phase 3

Metreleptin (Leptin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02262832 — Phase 3

Frequently Asked Questions

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

How many individuals are involved in this experiment?

"That is accurate. The clinicaltrials.gov website indicates that this trial, which was first posted on October 9th, 2014, is still recruiting patients. They are looking for 30 individuals at 2 locations."

Answered by AI

Are patients currently being signed up for this trial?

"This trial is actively searching for participants, as reported on clinicaltrials.gov. The study was initially posted on 10/9/2014 and was last updated on 9/23/2022."

Answered by AI

What goals does this research hope to achieve?

"This study seeks to observe changes in serum triglycerides over the course of 6 to 12 months. Additionally, this study will keep track of changes in bone mineral density & metabolism, steatohepatosis, and pituitary & reproductive function – with stability or improvement being the desired goal."

Answered by AI

Are there other times when this medical procedure was trialed before on people?

"According to the latest information, there are 5 clinical trials currently underway for this treatment. 2 of these studies have progressed to Phase 3. Many of the locations for these trials are in Bethesda, Maryland; although, 14 different sites are running these tests."

Answered by AI