Your session is about to expire
← Back to Search
Leptin Analog
Metreleptin for Lipomatosis
Phase 1
Waitlist Available
Led By Elif Oral
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
<60 years of age
<60 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
Study Summary
This trial will test the effects of Metreleptin on patients with a specific gene mutation. Over 6 months, they will track changes in the patients' weight, metabolism, and safety.
Who is the study for?
This trial is for individuals under 60 with Multiple Symmetric Lipomatosis (MSL), specifically those with a certain genetic mutation (homozygous MFN2 R707W). Participants must be able to undergo blood sampling, not have conditions affecting the study, and if female and of childbearing potential, they must not be pregnant or breastfeeding. They should also be patients at the University of Michigan.Check my eligibility
What is being tested?
The trial tests Metreleptin's effects on body composition and metabolic parameters in MSL patients over six months. It aims to evaluate both safety and efficiency by monitoring changes after administering Metreleptin.See study design
What are the potential side effects?
Potential side effects of Metreleptin may include allergic reactions for those sensitive to it, issues related to blood sampling such as bruising or infection, and other unspecified risks that could arise from altering metabolic parameters.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am younger than 60 years old.
Select...
I am younger than 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in total adiposity
Change in truncal adiposity
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: Patients with MSLExperimental Treatment1 Intervention
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?
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,934 Total Patients Enrolled
Amryt PharmaIndustry Sponsor
4 Previous Clinical Trials
416 Total Patients Enrolled
Elif OralPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a record of having HIV infection.You are not currently breastfeeding.You have been diagnosed with MSL and are being treated at the University of Michigan.You are not being excluded for general obesity unless it is caused by a specific medical condition called congenital leptin deficiency.I have had heart surgery or a stent due to blocked arteries and still experience chest pain.I am willing and able to follow the study's procedures.My medical records show I have advanced liver disease.You have been diagnosed with MSL and are being treated at the University of Michigan.I am okay with having my blood drawn for tests.I cannot walk or travel to the University of Michigan for study visits.Any other condition that we think might make it hard to collect accurate information.My medical records show I have a condition that could increase my bleeding risk.I do not have any ongoing infections like TB.I am willing and able to follow the study's procedures.You have an autoimmune disease.You are allergic to metreleptin.I am younger than 60 years old.If you are a woman who could become pregnant: You need to have a negative pregnancy test before starting the study.I have end-stage kidney disease, active cancer, or severe heart failure.Medical records show that you have a different cause of viral hepatitis.I am younger than 60 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with MSL
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Who else is applying?
What state do they live in?
Oklahoma
Kentucky
Texas
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger