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New treatment option for Hypothalamic Obesity
Official title A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
ClinicalTrials.gov ID: NCT06239116
What this study is testing
What is Part C: RM-718?
Part C: RM-718 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hypothalamic obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Key Parts A and B:
- Male and female people in good health aged 18-55 years of age at Screening.
- Body mass index (BMI) ≥30 kg/m2.
- people who are medically healthy with normal or clinically insignificant screening results.
- people must use a highly effective form of contraception and follow the study contraception requirements.
You likely can't join if
- 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...
- Obesity due to genetic, syndromic, or endocrine etiologies.
- History of renal transplant, end stage renal disease.
- Diagnosis of severe psychiatric disorders.
See the full eligibility criteria
- Key Parts A and B:
- Male and female people in good health aged 18-55 years of age at Screening.
- Body mass index (BMI) ≥30 kg/m2.
- people who are medically healthy with normal or clinically insignificant screening results.
- people must use a highly effective form of contraception and follow the study contraception requirements.
- Ability to communicate well with the Investigator, understand and comply with the requirements of the trial, and understand English and sign the written informed consent. Part C:
- Male and female patients with HO, aged 12-65 years of age at Screening.
- Patient has documented evidence of acquired HO defined as:
- Diagnosis of craniopharyngioma or other brain lesion affecting the hypothalamic region and has undergone surgery, or chemotherapy, or radiation therapy involving the hypothalamus at least 6 months before Screening, OR
- Documented injury to the hypothalamus at least 6 months before Screening for which surgery/radiation is not indicated.
- Weight gain associated with the hypothalamic injury either before or following therapy (surgery and/or following chemotherapy or radiotherapy), and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th...
- Patients must use a highly effective form of contraception and follow the study contraception requirements.
- Ability to communicate with the Investigator, understand and comply with the requirements of the trial, and understand and sign the written informed consent and assent (for patients aged \<18 years), and informed...
- Confirmed diagnosis of PWS as determined by the Investigator at the time of Screening.
- Age ≥12 to 65, inclusive, at the time of signing Informed Consent and/or Assent.
- BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex for patients \<18 years of age based on the US CDC criteria.
- Able to meet contraception requirements. Key
- 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...
- 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...
- 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. Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Nashville, Tennessee, United States; San Antonio, Texas, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.