A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

What Was Tested

This registered phase 1 trial tested Setmelanotide.

A total of approximately 32 subjects (approximately 8 subjects in each renal impairment group and 8 healthy subjects with normal renal function) are planned to be enrolled across 4 centers in the United States.

At screening, subjects will be assigned to a study group according to eGFR.

It had four arms (groups): Mild impairment (experimental), Moderate impairment (experimental), Severe impairment (experimental) and Normal (control) (experimental).

The registry classes the interventions as drug.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 83 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: The subject is male or female 18 to 83 years of age, inclusive. The subject has a BMI of 22 to 40 kg/m2, inclusive, at screening. The subject agrees to comply with all protocol requirements. The subject is able to provide written informed consent. The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.

The full record lists 14 inclusion and 25 exclusion criteria; among the exclusions: the subject has a positive test result for human immunodeficiency virus types 1 or 2 antibodies or hepatitis b surface antigen at screening; the subject has a history of alcoholism or drug abuse within 3 months before screening; the subject has alt or ast \>2 × uln at screening.

How the Study Was Run

Design: non-randomized, sequential and open-label.

Everyone knew when Setmelanotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-07-09 with completion listed for 2021-04-17.

It ran at 4 sites in United States (4).

Its stated primary purpose is other.

What Was Measured

It also tracked 4 secondary outcomes, for example Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment, Number of Participants with Abnormal Vital Sign Findings, Number of subjects with Abnormal Electrocardiogram (ECG) findings and Number of subjects with Abnormal Findings in Physical Examination.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Setmelanotide in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Setmelanotide compound page, all human trials.