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NCT01867437 · ClinicalTrials.gov registry record · Phase 1
Effects of RM-493 on Energy Expenditure in Obese Individuals
A Phase 1 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01867437 is a Phase 1 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 15 participants.
The verdict
NCT01867437, a Phase 1 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study 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 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 Om
Interventions
- DRUG Placebo
- DRUG RM-493
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01867437
The ClinicalTrials.gov registry entry for NCT01867437 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01867437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01867437 about?
NCT01867437 is a clinical study titled "Effects of RM-493 on Energy Expenditure in Obese Individuals". 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 meta...
What is the current status of trial NCT01867437?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2013-05. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01867437?
The interventions under investigation include: Placebo (DRUG), RM-493 (DRUG).
Who is sponsoring clinical trial NCT01867437?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
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