Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants

NCT01749137 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RM-493-003
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate the effects of RM-493 on mean percent body weight loss, and other weight loss parameters as well as Pharmacokinetic (PK) profile, and ambulatory blood pressure in obese participants. The study is designed to evaluate the efficacy and tolerability of a single dose of RM-493. The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion.

Conditions

Overweight

Keywords

Overweight

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Weight

  The mean percent change from baseline in body weight at Day 90 was analyzed.

  Baseline and Day 90

Secondary Outcomes (11)

• Change From Baseline in Body Weight

  Baseline and Day 90

• Percentage of Participants Who Lost ≥ 5% of Their Baseline Body Weight

  Baseline up to Day 90

• Number of Participants Who Consistently Achieved Targeted Plasma Concentration of ~6 Nanogram Per Milliliter (ng/mL)

  Day 1: pre-dose and 2-hours post-infusion, Day 7, 14, 28, 56, and 90

• Percentage of Participants With Treatment Emergent Adverse Events

  From first dose of study drug (Day 1) until end of study (Up to 184 days)

• Change From Baseline in Ambulatory Blood Pressure Monitoring Parameter (ABPM) - Systolic Blood Pressure

  Baseline and Day 28

Study Arms (2)

Setmelanotide

EXPERIMENTAL

Participants received 1 milligram (mg) setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.

Drug: Setmelanotide

Placebo

PLACEBO COMPARATOR

Participants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.

Drug: Placebo

Interventions

Setmelanotide DRUG

Daily subcutaneous infusion

Also known as: RM-493

Setmelanotide

Placebo DRUG

Daily subcutaneous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the age of 18 and 65.
• Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.
• In good general health, without significant medical history, physical examination findings, or clinical laboratory abnormalities.
• Body Mass Index: 35-50 Kg/m\^2, inclusive. It is planned that approximately 20 (but no more than 50% of the total participants enrolled) of these participants will have a BMI ≥ 40 Kg/m\^2
• Stable body weight (+/- 5 Kg) during previous 6 months.
• Blood pressure (\<150/95 mmHg); may include stable dose (≥ 30 days of use) of up to two anti-hypertensive medications to achieve control that are intended to remain on a stable dose during the protocol.
• Willingness and demonstrates ability to self-administer study medication subcutaneously via an infusion pump during the placebo practice period.
• Willing to maintain a healthy diet and exercise regime throughout study as recommended by counseling at study start.
• Females of childbearing potential must agree to be abstinent or else use any two of the following medically acceptable forms of contraception from the Screening Period through the completion of study treatment: hormonal, condom with spermicidal jelly, diaphragm or cervical cap with spermicidal jelly, or intrauterine device (IUD). Hormonal contraception must have started at least 3 months prior to screening. A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. Participants must agree to practice the above birth control methods for 30 days after completion of study treatment as a safety precaution.
• Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months (and confirmed with a screening follicle stimulating hormone (FSH) level in the post-menopausal range), do not require contraception during 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 90 days 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.

You may not qualify if:

• Fasting blood glucose \> than 140 mg/dL.
• Haemoglobin A1c (HbA1c) ≥6.5%.
• Thyroid stimulating hormone (TSH) level outside the normal range.
• Creatinine \> 1.5 times the upper limit of normal.
• Liver function tests \> 2 times the upper limit of normal.
• Active or history of any significant medical condition including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.
• Participants with a history of the following:
• Uncontrolled hypertension;
• Diabetes requiring medical treatment, presently or in the past;
• Major depressive disorder within the last 2 years;
• Any lifetime history of a suicide attempt;
• Any suicidal behavior in the last month;
• Other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder, severe eating disorders including bulimia).
• A patient health questionnaire - 9 (PHQ-9) score of ≥15.
• Any suicidal ideation of type 4 or 5 on the columbia suicide severity rating scale (C-SSRS).

Sponsors & Collaborators

• Rhythm Pharmaceuticals, Inc.: lead

Study Sites (6)

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Renton, Washington, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

setmelanotide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rhythm Clinical Trials
• Organization: Rhythm Pharmaceuticals, Inc

clinicaltrials@rhythmtx.com

857-264-4280

Study Officials

• David Meeker, MD

  Rhythm Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 13, 2012
• Study Start: January 14, 2013
• Primary Completion: September 28, 2013
• Study Completion: September 28, 2013
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)