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Leptin Analog

Metreleptin for Insulin Resistance

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
Diabetic symptoms with a random plasma glucose >= 200 mg/dL
Clinically significant, severe insulin resistance caused by a known or suspected defect in the insulin receptor
Must not have
Known HIV infection
Pregnant at time of enrollment, women in their reproductive years who do not use an effective method of birth control, and women currently nursing or lactating within 6 weeks of having completed nursing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change at month 12 from baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether metreleptin, a medication used to treat patients with leptin deficiency, will improve glycemia control in patients with genetic defects of the insulin receptor. The primary endpoint is hemoglobin A1c and the trial will enroll 20 patients at the NIH Clinical Center.

Who is the study for?
This trial is for males and females over the age of 5 with severe insulin resistance due to insulin receptor mutations. Participants must have diabetes as defined by ADA criteria, with fasting insulin >30 micro U/ml or glucose levels indicating diabetes. Pregnant women, those not using birth control, or with certain infections like HIV are excluded.
What is being tested?
The study tests if metreleptin therapy (0.2 mg/kg/day) can improve blood sugar control in patients with genetic defects in the insulin receptor over a year. It's an open-label study at NIH Clinical Center focusing on changes in Hemoglobin A1c and other blood sugar markers.
What are the potential side effects?
Potential side effects of metreleptin may include allergic reactions (especially in those sensitive to E. Coli proteins), weight loss, headaches, abdominal pain, and low blood sugar events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have diabetes symptoms and my blood sugar level is 200 mg/dL or higher.
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I have severe insulin resistance due to issues with my insulin receptor.
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I have been diagnosed with diabetes according to the ADA guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV positive.
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I am not pregnant, nursing, or lactating and use effective birth control.
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I have a liver infection.
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I am currently taking appetite suppressant drugs.
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I have active tuberculosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change at month 12 from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and change at month 12 from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HbA1C
Secondary study objectives
Change in Fasting Blood Glucose
Change in Fasting Insulin Level

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Leptin TreatmentExperimental Treatment1 Intervention
300 mg of study drug administered via subcutaneous (SC) injections.
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
2,464 Previous Clinical Trials
4,337,442 Total Patients Enrolled
Rebecca J Brown, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
1,544 Total Patients Enrolled

Media Library

Type 2 Diabetes Research Study Groups: Leptin Treatment
~0 spots leftby Dec 2025
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