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OverweightPhase 2NCT01749137

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

A Phase 2 study testing Setmelanotide in people with Overweight, run by Rhythm Pharmaceuticals, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight
What is being tested?
Setmelanotide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
6 sitesUnited States
Study dates
14 Jan 2013to 28 Sep 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • Prior bariatric surgery.
  • Treated with anorectic agents or drugs with anorexia as a frequent side event.
  • Taking 3 or more anti-hypertensive medications.
  • Acute illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the participant or obscure interpretation of laboratory test results or interpretation of study data.
  • History of human immunodeficiency virus (HIV) infection.
  • History of significant drug hypersensitivity or anaphylaxis.
  • History of hypersensitivity to proteins (e.g., allergy shots).
  • Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
  • Abnormal 12-lead electrocardiogram (ECG) at screening or pre-dose (Day 1), except minor deviations deemed to be of no clinical significance by the Investigator. QTc must be < 450 ms.
  • Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to dosing.
  • Hospitalization for surgery within the 3 months prior to screening except for minor outpatient procedures, or any planned hospitalizations during the study period.
  • Poor venous access or inability to tolerate venipuncture.
  • Inability to attend all study visits or comply with protocol requirements including fasting and restrictions on concomitant medication intake.
  • Participation in weight loss programs during the study period, including nutritional supplements/ replacements other than as recommended by nutritional counseling provided at study start.
  • Use of prescription medications on a regular basis with the following exceptions:
  • Contraceptives (must be on for ≥3 months);
  • Hormone replacement therapy (must be on stable dose for ≥3 months);
  • Antihypertensives (<3 medications on a stable dose for ≥ 30 days);
  • Statins (dose must be ≤ half the maximum dose; must be on a stable dose ≥3 months);
  • Fibrates (must be on stable dose for ≥3 months);
  • Niacin (must be on stable dose for ≥3 months);
  • Thyroxin (stable dose for ≥ 30 days);
  • The last use of any other prescription medication must have been greater than 5 half-lives for the specific medication or at least 14 days prior to randomization, whichever is longer.
  • Women who are pregnant or are breast feeding.
  • Previously randomized and dosed in this study or previously exposed to RM-493.
  • History of alcohol or drug abuse within 5 years of Screening Visit.
  • Any other reason, which in the opinion of the Investigator would confound proper evaluation of the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Dallas, Texas

  • Study site

    Lexington, Kentucky

  • Study site

    Miami, Florida

  • Study site

    Raleigh, North Carolina

  • Study site

    Renton, Washington

  • Study site

    Rochester, New York

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist in Obese Patients

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
Being tested
Setmelanotide, Placebo
Keywords
Overweight
Medical subject headings
Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SetmelanotideDrug

    Also called RM-493

    Daily subcutaneous infusion

  • PlaceboDrug

    Daily subcutaneous infusion

Study groups in NCT01749137
Study groupRoleWhat they receive
SetmelanotideExperimentalParticipants received 1 milligram (mg) setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
Receives: Drug: Setmelanotide
PlaceboPlacebo comparatorParticipants received placebo matching setmelanotide every day by continuous subcutaneous infusion using the Omnipod insulin pump for a duration of 90 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change From Baseline in Body Weight

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

    Measured: Baseline and Day 90

Secondary outcomes (11)

  1. Change From Baseline in Body Weight

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

    Measured: Baseline and Day 90

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

    The percentage of participants who lost ≥ 5% of their baseline body weight was analyzed. 95% confidence interval is calculated based on Clopper-Pearson.

    Measured: Baseline up to Day 90

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

    Number of Participants Who Consistently Achieved Targeted Plasma Concentration of ~6 ng/mL were reported.

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

  4. Percentage of Participants With Treatment Emergent Adverse Events

    An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An adverse event (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. A treatment-emergent AE was defined as an AE with an onset date on or after day 1.

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

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

    Summary of individual average data at daytime, nighttime and 24 hours was reported.

    Measured: Baseline and Day 28

  6. Change From Baseline in ABPM - Diastolic Blood Pressure

    Summary of individual average data at daytime, nighttime and 24 hours was reported.

    Measured: Baseline and Day 28

  7. Change From Baseline in ABPM - Mean Arterial Blood Pressure

    Summary of individual average data at daytime, nighttime and 24 hours was reported.

    Measured: Baseline and Day 28

  8. Change From Baseline in ABPM - Heart Rate

    Summary of individual average data at daytime, nighttime and 24 hours was reported.

    Measured: Baseline and Day 28

  9. Change From Baseline in ABPM - Pulse Pressure

    Summary of individual average data at daytime, nighttime and 24 hours was reported.

    Measured: Baseline and Day 28

  10. Percent Change From Baseline in Body Weight in Severely Obese Participants

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

    Measured: Baseline and Day 90

  11. Percentage of Participants Who Lost ≥ 5% of Their Baseline Body Weight in Severely Obese Participants

    The percentage of participants who lost ≥ 5% of their baseline body weight loss in severely obese participants was analyzed. 95% confidence interval is calculated based on Clopper-Pearson confidence interval.

    Measured: Baseline up to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2012 (estimated)
  2. Study start14 Jan 2013
  3. Primary completion28 Sep 2013
  4. Study completion28 Sep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01749137
Sponsor's protocol ID
RM-493-003
Status last verified
Jul 2023
First submitted
11 Dec 2012
Last updated
14 Aug 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Setmelanotide in people with Overweight, run by Rhythm Pharmaceuticals, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Body Weight (time frame: Baseline and Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01749137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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