Renal InsufficiencyPhase 1NCT04348175
A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
A Phase 1 study testing Setmelanotide in people with Renal Insufficiency, run by Rhythm Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect of renal impairment on the PK of 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… Read more about this study
- Who is it for?
- Ages 18 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Setmelanotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Jul 2020to 17 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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.
- Female subjects of childbearing potential must use an acceptable method of birth control (ie, diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) or be surgically sterile (ie, hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or postmenopausal (defined as amenorrhea 12 consecutive months and documented plasma follicle-stimulating hormone level in the postmenopausal range according to the laboratory used). Female subjects must have a negative pregnancy test at screening and before the first dose of study drug and must not be lactating.
- Male subjects with female partners of childbearing potential must be vasectomized, be willing to use an acceptable method of birth control, or practice abstinence during the study. Male subjects must not donate sperm during and for 90 days following their participation in the study.
- The subject agrees to comply with all protocol requirements.
- The subject is able to provide written informed consent.
Show all 17Show fewer
- Additional Inclusion Criteria for Subjects with Renal Impairment Only (Cohorts A, B, and C):
- The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.
- The subject's renal insufficiency or other related concomitant medical conditions (eg, hypertension, diabetes, anemia) have remained stable for at least 3 months before study drug dosing.
- The subject has a resting blood pressure of 90 to 165 mm Hg (systolic) and 45 to 100 mm Hg (diastolic). Measurement can be repeated if the subject has an elevated value that is not consistent with previous history.
- The subject has a QTcF of <500 msec.
- The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ECG results, and physical examination findings, except for findings that, as judged by the investigator, are consistent with the subject's renal impairment or other stable concomitant medical conditions.
- Additional Inclusion Criteria for Healthy Subjects Only (Cohort D):
- The subject has normal renal function (≥90 mL/min) as determined by eGFR calculated using the MDRD formula.
- The subject will be "matched" to previous Cohorts A, B, and C with regards to age, sex, and BMI characteristics. Each subject in Cohort D will be within 20% of the median age and BMI of the combined median age and BMI across Cohorts A, B, and C.
- The subject has a resting blood pressure of 90 to 150 mm Hg (systolic) and 40 to 100 mm Hg (diastolic).
- The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ECG results, and physical examination findings.
Who cannot join
- The subject has a history or clinical manifestations of a significant neurological, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, hepatic, genitourinary, endocrine, metabolic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- 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 is unable or unwilling to abstain from alcohol, marijuana and related substances, caffeine, cigarette smoking, vaping, or any form of tobacco or nicotine from 48 hours prior to study drug dosing until completing study assessments on Day 5.
- The subject is involved in strenuous activity or contact sports within 24 hours of the first dose of study drug or during the study.
- The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
Show all 27Show fewer
- The subject has a history of relevant drug and/or food allergies (ie, allergy to setmelanotide or any excipients, or any significant food allergy).
- The subject has used prescription drugs from 1 week prior to randomization and throughout the study, except for prescription medications used for the treatment of stable concomitant conditions; examples include the following: diabetes, hypertension, hypercholesterolemia, hyperlipidemia or hypothyroidism. Medications used to treat these indications are allowed, so long as the subject has been on a stable dose for at least 2 weeks prior to randomization and plans to continue a stable dose throughout the study.
- The subject has received study drug in another investigational study within 30 days of dosing.
- The subject has a positive test result for drugs of abuse (including marijuana, and except positive test results associated with prescription medications that have been reviewed and approved by the investigator) or alcohol at screening or before the first dose of study drug.
- The subject has ALT or AST >2 × ULN at screening.
- The subject has HbA1c >10%. With Sponsor approval, a subject who has a HbA1c >10% may be enrolled into the study if, in the opinion of the primary investigator, the subject's diabetes is reasonably controlled and the subject is otherwise appropriate for this study.
- The subject has any personal history of cancer (unless stable and in remission for ≥5 years), multiple atypical nevi, nevoid basal cell carcinoma syndrome, or nonmelanoma skin cancer requiring treatment beyond local excision.
- The subject has any close family history (parents or siblings) of melanoma.
- The subject has significant dermatologic findings relating to melanoma or premelanoma skin lesions, determined as part of a screening comprehensive skin evaluation performed by a qualified dermatologist, the principle investigator, or a nurse practitioner (ordered by preference) . Any concerning lesions identified during screening will be biopsied and results known to be benign prior to enrollment. If the pretreatment biopsy results are of concern, the subject may need to be excluded from the study.
- The subject has history of clinically significant recent surgery (within 60 days of screening).
- The subject has current or recent (within last month) infection or viral illness.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
- Additional Exclusion Criteria for Subjects with Renal Impairment Only (Cohorts A, B, and C):
- The subject has a positive test result for antibodies to hepatitis C virus with evidence of viral load at screening.
- The subject has nephrotic syndrome, defined as urine dipstick 4+ for protein and plasma albumin <3.0 g/dL, and then confirmed if proteinuria >5 g/day.
- The subject has renal impairment due to rapidly growing, space-occupying lesions (eg, carcinoma of the kidney, tuberculosis).
- Subject has a history of renal transplant.
- The subject has a hemoglobin value less than 8.0 g/dL.
- The subject has a clinically relevant immunologic disease.
- Additional Exclusion Criteria for Healthy Subjects Only (Cohort D):
- The subject has a positive test result for antibodies to hepatitis C virus at screening.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449
University of Miami
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect of renal impairment on the PK of 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.
Cohort A - Mild Renal Impairment
Cohort B - Moderate Renal Impairment
Cohort C - Severe Renal Impairment
Cohort D - Normal Renal Function (control)
- Conditions
- Renal Insufficiency
- Being tested
- Setmelanotide
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetmelanotideDrug
Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data.
| Study group | Role | What they receive |
|---|---|---|
| Mild impairment | Experimental | Not described Receives: Drug: Setmelanotide |
| Moderate impairment | Experimental | Not described Receives: Drug: Setmelanotide |
| Severe impairment | Experimental | Not described Receives: Drug: Setmelanotide |
| Normal (control) | Experimental | Not described Receives: Drug: Setmelanotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter - Peak Plasma Concentration (Cmax)
The primary objective of this study is to evaluate the PK of a single dose of Setmelanotide administered SC in subjects with varying degrees of renal impairment and that of healthy matched control subjects.
Measured: 5 days
Pharmacokinetic Parameter - Area under the plasma concentration versus time curve (AUC)
The primary objective of this study is to evaluate the PK of a single dose of Setmelanotide administered SC in subjects with varying degrees of renal impairment and that of healthy matched control subjects.
Measured: 5 days
Secondary outcomes (4)
Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
The secondary objective of this study is to evaluate the safety and tolerability of a single dose of Setmelanotide administered SC in subjects with varying degrees of renal impairment.
Measured: 5 days
Number of Participants with Abnormal Vital Sign Findings
Vital signs will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.
Measured: 5 days
Number of subjects with Abnormal Electrocardiogram (ECG) findings
Electrocardiogram assessments will include comments on whether the tracings are normal or abnormal, rhythm, presence of arrhythmia or conduction defects, wave morphology, any evidence of myocardial infarction, or ST-segment, T-Wave, and U Wave abnormalities.
Measured: 5 days
Number of subjects with Abnormal Findings in Physical Examination
A full physical examination will include, at minimum, assessment of skin, head, ears, eyes, nose, throat, neck, thyroid, lungs, heart, cardiovascular, abdomen, lymph nodes, and musculoskeletal system/extremities.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start9 Jul 2020
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348175
- Sponsor's protocol ID
- RM-493-029
- Status last verified
- Jun 2021
- First submitted
- 30 Mar 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT04348175
- Acronym / sponsor ID
- RM-493-029
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, multi-center, open-label, single-dose study designed to assess the effect of renal impairment on the PK of 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.
Cohort A - Mild Renal Impairment
Cohort B - Moderate Renal Impairment
Cohort C - Severe Renal Impairment
Cohort D - Normal Renal Function (control)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild impairment | Experimental | Drug: Setmelanotide |
| Moderate impairment | Experimental | Drug: Setmelanotide |
| Severe impairment | Experimental | Drug: Setmelanotide |
| Normal (control) | Experimental | Drug: Setmelanotide |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Female subjects of childbearing potential must use an acceptable method of birth control (ie, diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) or be surgically sterile (ie, hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or postmenopausal (defined as amenorrhea 12 consecutive months and documented plasma follicle-stimulating hormone level in the postmenopausal range according to the laboratory used). Female subjects must have a negative pregnancy test at screening and before the first dose of study drug and must not be lactating.
- Male subjects with female partners of childbearing potential must be vasectomized, be willing to use an acceptable method of birth control, or practice abstinence during the study. Male subjects must not donate sperm during and for 90 days following their participation in the study.
- The subject agrees to comply with all protocol requirements.
Key exclusion criteria (27 listed)
- The subject has a history or clinical manifestations of a significant neurological, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, hepatic, genitourinary, endocrine, metabolic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- 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 is unable or unwilling to abstain from alcohol, marijuana and related substances, caffeine, cigarette smoking, vaping, or any form of tobacco or nicotine from 48 hours prior to study drug dosing until completing study assessments on Day 5.
- The subject is involved in strenuous activity or contact sports within 24 hours of the first dose of study drug or during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SetmelanotideSetmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data. | Drug | Mild impairment, Moderate impairment, Normal (control), Severe impairment |
Primary outcome
Pharmacokinetic Parameter - Peak Plasma Concentration (Cmax)
Time frame: 5 days
The primary objective of this study is to evaluate the PK of a single dose of Setmelanotide administered SC in subjects with varying degrees of renal impairment and that of healthy matched control subjects.
Pharmacokinetic Parameter - Area under the plasma concentration versus time curve (AUC)
Time frame: 5 days
The primary objective of this study is to evaluate the PK of a single dose of Setmelanotide administered SC in subjects with varying degrees of renal impairment and that of healthy matched control subjects.
4 secondary outcomes
Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: 5 days
Number of Participants with Abnormal Vital Sign Findings
Time frame: 5 days
Number of subjects with Abnormal Electrocardiogram (ECG) findings
Time frame: 5 days
Number of subjects with Abnormal Findings in Physical Examination
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Related trials for Renal Insufficiency
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Setmelanotide in people with Renal Insufficiency, run by Rhythm Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameter - Peak Plasma Concentration (Cmax) (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.