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

Exclusion Criteria

• •Parts A and B
• •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.
• •Diagnosis of severe psychiatric disorders.
• •Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
• •Cigarette smoking or dependence on caffeine, alcohol or drugs; unable or unwilling to abstain completely from caffeine, alcohol and related substances for 24 hours prior to and after study visits.
• •History of recent surgery (within 60 days of Screening).
• •Participation in any clinical trial with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose.
• •Pregnant and/or breastfeeding or desiring to become pregnant during this trial.
• •Part C
• •Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET).
• •Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 12 to \<18 years and/or anti-obesity medications for the treatment of obesity.
• •Bariatric surgery or procedure within the last 2 years.
• •Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior.
• •Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
• •History of renal transplant, end stage renal disease.
• •Participation in any clinical trial with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose, or previous participation in a trial with setmelanotide.
• •Pregnant and/or breastfeeding or desiring to become pregnant during this trial.
• •Obesity attributable to other genetic or syndromic conditions (eg, PPL \[pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), leptin receptor (LEPR), collectively\], Bardet-Biedl syndrome \[BBS\]) prior to the hypothalamic injury.
• •Part D
• •Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 12 to \<18 years or therapies for the treatment of obesity or hyperphagia.
• •Metabolic and bariatric surgery (MBS) or procedure within last 6 months.
• •Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior.
• •Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and/or confound the results.
• •Pregnant and/or breastfeeding or desiring to become pregnant during this trial.