Health TrialsbyHealthPanel

A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment

ConditionsHypothalamic ObesityPrader-Willi SyndromePWS
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorRhythm Pharmaceuticals, Inc.

About this trial

The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female subjects in good health aged 18-55 years of age at Screening.

Body mass index (BMI) ≥30 kg/m2.

Subjects who are medically healthy with normal or clinically insignificant screening results.

Subjects must use a highly effective form of contraception and follow the study contraception requirements.

Disqualifiers

Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator.

Active or history of any significant medical condition such as and including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.

Obesity due to genetic, syndromic, or endocrine etiologies.

History of renal transplant, end stage renal disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Part A: RM-718 or placebo (matched to specific RM-718 dose cohort)

    Drug

    Single ascending dose of RM-718 or placebo (matched to specific RM-718 Part A dose cohort)

  • Part B: RM-718 or placebo (matched to specific RM-718 dose cohort)

    Drug

    Multiple ascending doses of RM-718 or placebo (matched to specific RM-718 Part B dose cohorts)

  • Part C: RM-718

    Drug

    Multiple ascending doses of RM-718

  • Part D: RM-718

    Drug

    Multiple ascending doses of RM-718

Treatment groups

150 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Group A: RM-718 (Cohort A1)Experimental treatment 1 intervention
Group B: RM-718 (Cohort A2)Experimental treatment 1 intervention
Group C: RM-718 (Cohort A3)Experimental treatment 1 intervention
Group D: RM-718 (Cohort A4)Experimental treatment 1 intervention
Group E: RM-718 (Cohort A5)Experimental treatment 1 intervention
Group F: RM-718 (Cohort A6)Experimental treatment 1 intervention
Group G: RM-718 (Cohort A7)Experimental treatment 1 intervention
Group H: RM-718 (Cohort A8)Experimental treatment 1 intervention
Group I: RM-718 (Cohort A9)Experimental treatment 1 intervention
Group J: RM-718 (Cohort B1)Experimental treatment 1 intervention
Group K: RM-718 (Cohort B2)Experimental treatment 1 intervention
Group L: RM-718 (Cohort B3)Experimental treatment 1 intervention
Group M: RM-718 (Cohort B4)Experimental treatment 1 intervention
Group N: RM-718 (Cohort B5)Experimental treatment 1 intervention
Group O: RM-718 (Cohort B6)Experimental treatment 1 intervention
Group P: RM-718 (Cohort C1)Experimental treatment 1 intervention
Group Q: RM-718 (Cohort D1)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Parts A, B, C, D: Safety and Tolerability Assessed by Number of Study Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 through the Safety-Follow-up call (up to Day 43 for all Part A cohorts, up to Day 70 for all Part B cohorts, up to Day 140 for Part C cohort, up to Day 210 for Part D cohort)

Secondary outcomes

1

AUCtau measurement of RM-718

Area under the concentration versus time curve during a dosing interval

Time frame
up to 168 hours post-dose on Day 1 (Parts A, B and C) and 168 hours post-dose on Day 22 (Parts B and C).
2

Cmax measurement of RM-718

Maximum concentration measurement of RM-718 in plasma

Time frame
up to 168 hours post-dose on Day 1 (Parts A, B and C) and 168 hours post-dose on Day 22 (Parts B and C).
3

Cmin measurement of RM-718

Minimum plasma concentration of RM-718 reached during dosing interval

Time frame
up to 168 hours post-dose on Day 1 (Parts A, B and C) and 168 hours post-dose on Day 22 (Parts B and C).
4

Tmax measurement of RM-718

Time it takes for RM-718 to reach the maximum concentration (Cmax)

Time frame
up to 168 hours post-dose on Day 1 (Parts A, B and C) and 168 hours post-dose on Day 22 (Parts B and C).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rhythm Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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