Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

NCT02041195 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: RM-493-009
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.

Conditions

Overweight and Obesity

Keywords

Overweight

Outcome Measures

Primary Outcomes (9)

• Body Weight - Stage A

  Baseline

• Percent Change From Baseline in Body Weight at Week 12 - Stage A

  Baseline, Week 12

• Body Weight - Stage B

  Baseline

• Percent Change From Baseline in Body Weight at Week 12 - Stage B

  Baseline, Week 12

• Body Weight - Stage C

  Baseline

• Percent Change From Baseline in Body Weight at Week 12 - Stage C

  Baseline, Week 12

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) - Stage A

  An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.

  From first dose up to Day 114

• Number of Participants With TEAEs - Stage B

  An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.

  From first dose up to Day 114

• Number of Participants With TEAEs - Stage C

  An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs that occurred after the start of study drug administration were considered TEAEs.

  From first dose up to Day 114

Secondary Outcomes (6)

• Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage A

  Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 22, and 24 hours after dosing on Day 8

• Mean Setmelanotide Concentrations During a 24-Hour Steady State Interval on Day 8 - Stage C

  Predose (0 hours) and at 1, 2, 4, 6, 8, 10, 12, 14 and 24 hours after dosing on Day 8

• Change From Baseline in Ambulatory Blood Pressure Monitoring (ABPM) Parameters During 24-Hour Interval Between Days 8 and 15 - Stage A

  Baseline and for one 24-hour interval between Days 8 or 15

• Change From Baseline in ABPM Parameters During 24-Hour Interval Between Days 8 and 15 - Stage C

  Baseline and for one 24-hour interval between Days 8 or 15

• Change From Baseline in Heart Rate Using ABPM During 24-Hour Interval Between Days 8 and 15 - Stage A

  Baseline and for one 24-hour interval between Days 8 and 15

Study Arms (3)

Setmelanotide Once Daily

ACTIVE COMPARATOR

Once daily in the morning, equivalent placebo in evening.

Drug: Setmelanotide; Drug: Placebo

Setmelanotide Split Dose

ACTIVE COMPARATOR

Split dose, one half in the morning and one half in the evening.

Drug: Setmelanotide

Placebo

PLACEBO COMPARATOR

Placebo in the morning, placebo in the evening.

Drug: Placebo

Interventions

Setmelanotide DRUG

Also known as: RM-493

Setmelanotide Once Daily; Setmelanotide Split Dose

Placebo DRUG

Placebo; Setmelanotide Once Daily

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 ages of 18 and 65 years, inclusive.
• 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: 30 to 40 Kg/m2.
• Stable body weight by participant report (+/- 5 Kg) during previous 6 months.
• Blood pressure (\<140/90 mmHg); may include stable dose (≥ 30 days of use) of up to two anti-hypertensive medications to achieve control and that are intended to remain on a stable dose during the protocol.
• Willingness (during screening) and demonstrated ability (as witnessed in the clinic prior to randomization) to self-administer study medication subcutaneously via a once or twice daily SC injection using a small insulin syringe.
• Willing to maintain a healthy diet and exercise regime throughout study as recommended by counseling at study start.
• Female participants must have negative serum pregnancy test and must not be lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method (i.e., sponge), or a double-barrier method of birth control (i.e., condom with spermicide) or abstinence must be used/ practiced throughout the study and for 90 days following the study.
• 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 FSH level in the post-menopausal lab range), do not require contraception during the study.
• Males with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study and for 90 days following the study. Male participants must not donate sperm for 90 days following their participation in the study.

You may not qualify if:

• Fasting blood glucose \> than 140 mg/dL.
• 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.
• Patients with a history of the following:
• Uncontrolled hypertension;
• Diabetes requiring medical treatment;
• Major depressive disorder within the last 2 years;
• Any lifetime history of a suicide attempt;
• Any suicidal ideation/behavior in the last month;
• Other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder, severe eating disorders including bulimia).
• A PHQ-9 score of ≥15.
• Any suicidal ideation of type 4 or 5 on the C-SSRS.
• Prior bariatric surgery.

Sponsors & Collaborators

• Rhythm Pharmaceuticals, Inc.: lead

Study Sites (2)

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 7, 2023
• Results First Posted: August 7, 2023

Record last verified: 2023-07

Locations

US (2)