Effects of RM-493 on Energy Expenditure in Obese Individuals

Completed · Phase 1 · Has a placebo group

Conditions studied: Obesity, Morbid Obesity

In brief

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 not fully known whether RM-493 causes weight loss by just decreasing appetite or by increasing metabolism or both. Researchers want to see how RM-493 affects metabolism and hormones that affect the metabolic rate. They also want to see how RM-493 affects appetite by assessing feelings of hunger and fullness. They will study this drug in people who are obese but are otherwise in good health. Objectives: \- To see how RM-493 affects metabolic rate and appetite in obese but otherwise healthy individuals. Eligibility: \- Individuals between 18 and 50 years old who are obese (body mass index between 30 and 40 kg/m2) but are otherwise healthy. Design: * The study consists of three phases. The first phase is the screening visit. The second phase is an 8-day inpatient stay. The final phase is a follow-up phone call one week after the end of the second phase. * Participants will be divided into two groups. One group will receive the study drug first, followed by a placebo. The other group will receive the placebo followed by the study drug. The study drug and placebo will be given under the skin for 3 days each by a small device (OmniPod) that normally is used to give insulin to people with diabetes. * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. They will also meet with a dietitian. The OmniPod device will be demonstrated before use. * Participants will have the following procedures during their 8-day inpatient stay: * Daily exercise routine (walking on treadmill) after setting a comfortable pace (miles per hour) during an exercise test * Wear physical activity monitors * Body composition study to measure amounts of fat and muscle * Calorie controlled study diet * Study drug/placebo dose through the OmniPod (Days 2 through 4 and 5 through 7) * Metabolic rate studies using a cart or the metabolic chamber * Daily blood samples * Urine collection for 24 hours * Questions about weight history and appetite * About a week after the inpatient stay, participants will have a followup phone call to ask about any side effects from the study.

Key facts

Study ID

NCT01867437

Run by

Rhythm Pharmaceuticals, Inc.

People needed

15

Starts

2013-05-01

Expected to finish

2014-03-01

Last updated by the study team

2017-04-20

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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