Nashville, TNNCT06239116Now EnrollingIRB Ready

Hypothalamic Obesity Clinical Trial in Nashville, TN

Access cutting-edge hypothalamic obesity treatment through this clinical trial at a research site in Nashville. Study-provided care at no cost to qualified participants.

Sponsored by Rhythm Pharmaceuticals, Inc.

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Expert Care in Nashville

Access hypothalamic obesity specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hypothalamic obesity treatment provided free

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Check if you qualify for this hypothalamic obesity clinical trial in Nashville, TN

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Why Participate?

  • No-Cost Study Care

  • Local to Nashville

    Convenient for TN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Nashville site if eligible
  4. 4Begin participation

About This Hypothalamic Obesity Study in Nashville

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

Sponsor: Rhythm Pharmaceuticals, Inc.

Who Can Participate

Inclusion Criteria

Parts A and B:
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.
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 percentile for age and sex for patients 12 to \<18 years of age.
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 consent for a parent or guardian of any patient \<18. Part D:
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

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. Other protocol defined Inclusion/Exclusion criteria may apply.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Nashville?

Yes, this clinical trial (NCT06239116) has an active research site in Nashville, TN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hypothalamic Obesity Treatment Options in Nashville, TN

If you're searching for hypothalamic obesity treatment options in Nashville, TN, this clinical trial (NCT06239116) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Nashville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hypothalamic obesity specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hypothalamic obesity clinical trials near you to find additional studies recruiting in your area.

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