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Metreleptin for Generalized Lipodystrophy
Phase 4
Waitlist Available
Research Sponsored by Aegerion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male patients must be surgically sterile or be willing to use an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent)
Physician-confirmed diagnosis of congenital or acquired generalized lipodystrophy and will begin treatment with MYALEPT for the first time
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and months 1, 2, 4, 6, 9, 12, 18, 24, 30, 36
Awards & highlights
Study Summary
This trial assesses the potential risks of metreleptin, a drug used to treat complications from leptin deficiency.
Who is the study for?
This trial is for individuals over 1 year old with congenital or acquired generalized lipodystrophy who are starting MYALEPT treatment. Participants need to consent, use contraception if of childbearing potential, and not have used metreleptin before. They shouldn't be at high risk as per the investigator's opinion, have a recent history of substance abuse, HIV positive status, or severe reactions to metreleptin.Check my eligibility
What is being tested?
The study tests the immune response to Metreleptin in patients with generalized lipodystrophy. It's an open-label Phase 4 trial assessing risks associated with developing antibodies against Metreleptin following its market approval.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Metreleptin or its components. Since it's an immunogenicity study focusing on antibody development, other specific side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male either surgically sterile or willing to use barrier contraception during the study.
Select...
I have been diagnosed with lipodystrophy and will start MYALEPT treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and months 1, 2, 4, 6, 9, 12, 18, 24, 30, 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and months 1, 2, 4, 6, 9, 12, 18, 24, 30, 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who develop anti-metreleptin/leptin antibodies at any timepoint after treatment with metreleptin
Percentage of participants who develop anti-metreleptin/leptin antibodies with neutralizing activity at any timepoint after treatment with metreleptin
Secondary outcome measures
Percentage of participants with SAEs, AESIs or adverse events leading to discontinuation
Percentage of participants with neutralizing or non-neutralizing antibodies who also show one or several of: a. Significant change of HbA1c b. Significant change of triglycerides c. Concomitant SAEs, AESIs or AEs leading to discontinuation
Other outcome measures
Percentage of participants who show a significant change in fasting triglycerides
Percentage of participants who show a significant change in hemoglobin A1c
Side effects data
From 2015 Phase 2 trial • 103 Patients • NCT0002588315%
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: MetreleptinExperimental Treatment1 Intervention
Subjects will receive prescribed dosage of metreleptin as indicated in the USPI Patients (males and females) ≤ 40 kg: 0.06mg/kg Male patients > 40 kg: 2.5mg Female patients > 40 kg: 5mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metreleptin
FDA approved
Find a Location
Who is running the clinical trial?
Aegerion Pharmaceuticals, Inc.Lead Sponsor
19 Previous Clinical Trials
1,629,940 Total Patients Enrolled
1 Trials studying Generalized Lipodystrophy
100 Patients Enrolled for Generalized Lipodystrophy
Janet BoylanStudy DirectorAegerion Pharmaceuticals, Inc.
1 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will not donate blood during the study or for 3 months after my last dose of metreleptin.My kidney function, measured by creatinine clearance, is below 30 mL/min.I am HIV positive, have a weakened immune system, or am taking drugs that affect my immune system.I am using or willing to use approved birth control methods if I can have children.You had a serious allergic reaction to metreleptin or any of its ingredients before.I am a male either surgically sterile or willing to use barrier contraception during the study.I have been treated with metreleptin before.I am currently pregnant or breastfeeding.I have been diagnosed with lipodystrophy and will start MYALEPT treatment.I am at least 1 year old.Women who could possibly become pregnant must have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Metreleptin
Awards:
This trial has 4 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current sample size of this research initiative?
"Affirmative. Clinicaltrials.gov data reveals that this research project, originally posted on November 14th 2018, is actively recruiting subjects. Approximately 10 individuals are sought from 8 different medical sites."
Answered by AI
Has Metreleptin been studied extensively in the past?
"Currently, 5 clinical trials are actively studying Metreleptin. Of these studies, 2 have entered Phase 3 and require patient participation. The primary location for the research is in Bethesda, Maryland; however 14 other locations across America are also running similar investigations."
Answered by AI
Has the U.S. Food and Drug Administration accepted Metreleptin as a viable treatment option?
"Metreleptin is a medication that has been approved by the FDA, thus our team gave it an safety rating of 3."
Answered by AI
Are there still opportunities to join this research endeavor?
"Data from clinicaltrials.gov indicates that this ongoing trial, first posted in November 2018 and updated on October 28th 2022, is actively recruiting patients."
Answered by AI
How many health care facilities are currently participating in this research program?
"8 recruitment locations are currently taking part in this trial, including University Texas Southwestern INT (Dallas), Univ. Alabama-Birmingham (Birmingham) and University of Michigan (Ann Arbor). Additionally, there are 5 other sites available to enrol participants."
Answered by AI
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