Status:
COMPLETED
Effects of RM-493 on Energy Expenditure in Obese Individuals
Lead Sponsor:
Rhythm Pharmaceuticals, Inc.
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Morbid Obesity
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Background: \- RM-493 is a drug that stimulates parts of the brain that control eating and metabolism. It has helped to reduce body weight and improve insulin sensitivity in lab tests. However, it is...
Detailed Description
Obesity is a chronic relapsing health problem and a strong risk factor for type 2 diabetes, hypertension, heart disease and stroke. Life expectancy is shorter in obese individuals who often suffer fro...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male and female subjects aged 18 to 50 years at screening who meet the following inclusion and exclusion criteria will be eligible for enrollment:
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
- Body mass index of 30-40 kg/m(2)
- Subjects who are medically healthy with normal or clinically insignificant screening results (laboratory profiles, medical histories, electrocardiograms and physical examination)
- Female subjects must have negative serum or urine pregnancy tests and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control or abstinence must be used/ practiced throughout the study. Female subjects unable to bear children must have this documented in the case report form (CRF) (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\]). Post-menopausal status will be confirmed by follicle stimulating hormone (FSH).
- Female subjects must have a negative serum pregnancy test prior to administering the OmniPod in both Period 1 and Period 2 to continue in the study.
- Males with female partners of childbearing potential must agree to use two medically acceptable forms of contraception as described above, with one of the two forms being condom with spermicide, from the Screening Period through the follow up phone call after completion of study treatment. Males with female partners of childbearing potential who themselves are surgically sterile (status post vasectomy) must agree to use condoms with spermicide over the same period of time.
- EXCLUSION CRITERIA:
- Pregnant or lactating women
- Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator
- Abnormal 12-lead electrocardiogram (ECG) except minor deviations deemed to be of no clinical significance by the Investigator
- ALT or AST \> 1.5 times the upper limit of normal (ULN) during screening
- Treated or untreated hypertension or blood pressure 140/90
- Treated or untreated diabetes diagnosed as fasting plasma glucose 126 or a HbA1c 6.5%
- TSH outside of the normal range
- 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.
- Clinical symptoms of or treatment for sleep apnea (severe snoring, excessive daytime somnolence)
- Any history of cancer, including personal history or close family history (parents or siblings) of melanoma; and/or personal history of multiple atypical nevi, nevoid basal cell carcinoma syndrome, or a personal history of non-melanoma skin cancer.
- Bariatric surgery
- History of recent surgery (within 60 days of screening)
- Current or recent (within last month) infection or viral illness
- Prescription drug use including topical steroids and inhalers, and non-prescription medicines with sympathomimetic actions (eg decongestants) if not stopped 1 week prior to and throughout the admission.
- Weight loss or gain of greater than 3% of body weight in last 3 months
- Inflexible dietary restrictions
- Actively training athletes (collegiate or professional level)
- Cigarette smoking (must be completely nonsmoking for at least 2 months)
- Dependence on caffeine, alcohol or drugs; unable or unwilling to abstain completely from caffeine and related substances for 72 hours prior to study and throughout the study
- Claustrophobia or other psychiatric conditions that would preclude participation in all aspects of the study
- Unable or unwilling to wear an insulin pump for the 6 days of treatment during the study (to deliver test drug and placebo)
- Participation in an investigational clinical study within the 30 days prior to dosing in the present study
- Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01867437
Start Date
May 1 2013
End Date
March 1 2014
Last Update
April 20 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892