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Hormone Therapy

Leptin + Pramlintide for Obesity

N/A

Waitlist Available

Led By Jonathan Q. Purnell, M.D.

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 year to 45 years of age

MI 18 to 25 kg/m2 or ≥ 30 kg/m2 at maximal lifetime weight

Must not have

Renal or hepatic impairment

Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 90 minutes

Awards & highlights

Approved for 5 Other Conditions

Summary

This trial is testing how well leptin and amylin work in obese people who have not been able to lose weight with other diets.

Who is the study for?

This trial is for adults aged 18-45 who are at their maximum lifetime weight and have maintained a stable weight for the last three months. They must have a BMI of either 18-25 or over 30. People with allergies to the study drugs, metal in their body, major illnesses, or those on certain medications cannot participate.

What is being tested?

The study is examining how leptin and amylin hormones affect brain regions involved in body weight control. Participants will receive infusions of metreleptin, pramlintide (amylin), both combined, or a placebo (normal saline) to assess this response using functional MRI.

What are the potential side effects?

Potential side effects from metreleptin and pramlintide may include allergic reactions due to sensitivity to E. coli-derived proteins used in these hormones' production process.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 45 years old.

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My BMI is either between 18-25 or was 30 or more at my heaviest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney or liver problems.

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I have a major illness or need prescription medicine for conditions like cancer, heart disease, high blood pressure, or diabetes.

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I do not have metal implants or objects in my body that could interfere with strong magnetic fields.

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I am not allergic to metreleptin or pramlintide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.

Secondary study objectives

Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.