Effects of RM-493 on Energy Expenditure in Obese Individuals

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 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.

Conditions

• Obesity
• Morbid Obesity

Interventions

DRUG

Placebo

Sterile solution (vehicle) for subcutaneous infusion

DRUG

RM-493

Sterile solution (2mg/ml) for subcutaneous infusion

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Rhythm Pharmaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Monica C Skarulis, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-03-31

Completion

2014-03-31

FDA Drug

Yes

Countries

• United States

Study Locations