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Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

Primary Purpose

Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Setmelanotide

About this trial

This is an interventional treatment trial for Genetic Obesity focused on measuring Pro-opiomelanocortin (POMC) deficiency obesity, LepR deficiency obesity, Smith-Magenis Syndrome, MC4R deficiency obesity, SRC1 deficiency obesity, SH2B1 deficiency obesity

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with the following genotypes and/or clinical assessment:
1. POMC/PCSK1/LEPR heterozygous - not currently enrolling new patients
2. POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity
3. POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity
4. Smith-Magenis Syndrome (SMS)
5. SH2B1 deficiency obesity
6. Chromosomal rearrangement of the 16p11.2 locus causing obesity
7. CPE compound heterozygous or homozygous deficiency obesity
8. Leptin deficiency obesity with loss of response to metreleptin
9. SRC1 deficiency obesity
10. MC4R deficiency obesity
Age 6 years and above
Obese, defined as Body Mass Index (BMI) ≥ 30 kg/m2 for patients ≥16 years of age or BMI≥ 95th percentile for age and gender for patients 6 up to 16 years of age.
Patient and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent
Female participants of child-bearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol.
Male participants with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study. Male patients must not donate sperm during and for 90 days following their participation in the study.

Key Exclusion Criteria:

Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents that has resulted in > 2% weight loss.
Use of any medication that is approved to treat obesity within three months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion).
Gastric bypass surgery within the previous six months or any prior gastric bypass surgery resulting in >10% weight loss durably maintained
Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
Suicidal ideation, attempt or behavior
Clinically significant pulmonary, cardiac, or oncologic disease
HbA1c >9.0% at Screening
History of significant liver disease
Glomerular filtration rate (GFR) <30 mL/min at Screening.
History or close family history of melanoma or patient history of oculocutaneous albinism
Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions.
Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
Patients previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
Inability to comply with QD injection regimen.
Females who are breastfeeding or nursing.

Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC
Synexus Clinical Research US, Inc. - Phoenix Southeast
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Honor Health Research Institute
Axis Clinical Trials-Downtown
Axis Clinical Trials Headquarters
San Diego Wake Research
Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus
Division of Endocrinology and Diabetes Children's National Hospital
University of Florida College of Medicine
AXIS South Florida Clinical Trials
Florida Hospital
Synexus Clinical Research US, Inc. - St. Petersburg
Synexus Clinical Research US, Inc. - Chicago
Maine Medical Partners
NIH Hatfield Clinical Research Center
Baystate Medical Center
University of Michigan Medicine
Precision Medicine for Obesity Research: Gastroenterology & Hepatology Mayo Clinic
Washington University St. Louis
Impact Clinical Trials
AXIS New York Clinical Trials
University at Buffalo
AXIS Clinical Trials
Icahn School of Medicine at Mount Sinai
Columbia University
Duke University Medical Center
Wake Research Inc.
Synexus Clinical Research US, Inc. - Akron
Synexus Clinical Research US, Inc. - Cincinnati
Synexus Clinical Research US, Inc. - Columbus
Obesity Institute, Geisinger Clinic
Childrens Hospital of Philadelphia
Synexus Clinical Research US, Inc. - Primary Care Associates, PC
Wake Research TN
Le Bonheur Children's Hospital
Vanderbilt University School of Medicine
Baylor College of Medicine
Synexus Clinical Research US, Inc. - Plano
Synexus Clinical Research US, Inc. - San Antonio
University of Utah
Seattle Children's Research Institute
Marshfield Clinic Research Institute
University of Alberta
Hopital Trousseau - Nutrition et Gastroentérologie
Hopital de la Pitié-Salpêtrière
Service de pédiatrie CHU de la Réunion - Hôpital Félix Guyon
Charité Berlin
University of Leipzig
University of Ulm
University General Hospital of Patras
Edmond and Lily Safra Children's Hospital
Erasmus MC
Hospital Infantil Universitario Niño Jesús
University Hospitals Birmingham NHS Foundation Trust
Addenbrooke's Hospital
Hammersmith Hospital
Hammersmith Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

16p11.2 Cohort

AS Cohort

BBS Cohort

MC4R Cohort

POMC/PCSK1/LEPR Heterozygous Cohort

POMC/PCSK1/LEPR Composite Heterozygous Cohort

POMC/PCSK1/LEPR Compound Heterozygous Cohort

SH2B1 Cohort

SMS Cohort

SRC1 Cohort

Arm Description

Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.

Outcomes

Primary Outcome Measures

Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment

Secondary Outcome Measures

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

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 AE (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. TEAEs were defined as AEs reported after dosing on Day 1.

Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment

Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment

Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years

The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.

Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years

The mean change in daily hunger questionnaire scores for participants < 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.

Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years

For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.

Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years

For participants < 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.

Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment

Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.

Full Information

NCT ID

NCT03013543

First Posted

January 3, 2017

Last Updated

July 25, 2023

Sponsor

Rhythm Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03013543

Brief Title

Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

Official Title

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 10, 2017 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhythm Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency

Keywords

Pro-opiomelanocortin (POMC) deficiency obesity, LepR deficiency obesity, Smith-Magenis Syndrome, MC4R deficiency obesity, SRC1 deficiency obesity, SH2B1 deficiency obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

213 (Actual)

8. Arms, Groups, and Interventions

Arm Title

16p11.2 Cohort

Arm Type

Experimental

Arm Description

Arm Title

AS Cohort

Arm Type

Experimental

Arm Description

Arm Title

BBS Cohort

Arm Type

Experimental

Arm Description

Arm Title

MC4R Cohort

Arm Type

Experimental

Arm Description

Arm Title

POMC/PCSK1/LEPR Heterozygous Cohort

Arm Type

Experimental

Arm Description

Arm Title

POMC/PCSK1/LEPR Composite Heterozygous Cohort

Arm Type

Experimental

Arm Description

Arm Title

POMC/PCSK1/LEPR Compound Heterozygous Cohort

Arm Type

Experimental

Arm Description

Arm Title

SH2B1 Cohort

Arm Type

Experimental

Arm Description

Arm Title

SMS Cohort

Arm Type

Experimental

Arm Description

Arm Title

SRC1 Cohort

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Setmelanotide

Other Intervention Name(s)

RM-493

Intervention Description

RM-493 QD SC injection

Primary Outcome Measure Information:

Title

Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment

Time Frame

Baseline to Month 3

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

From first dose up to Month 16

Title

Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment

Time Frame

Baseline, Month 3

Title

Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment

Time Frame

Baseline, Month 3

Title

Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years

Description

Time Frame

Baseline, Month 3

Title

Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years

Description

Time Frame

Baseline, Month 3

Title

Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years

Description

Time Frame

Baseline, Month 3

Title

Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years

Description

Time Frame

Baseline, Month 3

Title

Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment

Description

Time Frame

Baseline, Month 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants with the following genotypes and/or clinical assessment: POMC/PCSK1/LEPR heterozygous - not currently enrolling new participants POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity SMS SH2B1 deficiency obesity Chromosomal rearrangement of the 16p11.2 locus causing obesity Carboxypeptidase E (CPE) compound heterozygous or homozygous deficiency obesity Leptin deficiency obesity with loss of response to metreleptin SRC1 deficiency obesity MC4R deficiency obesity Age 6 years and above Obese, defined as Body Mass Index (BMI) ≥ 30 kilogram per meter square (kg/m^2) for participants ≥16 years of age or BMI≥ 95th percentile for age and gender for participants 6 up to 16 years of age. Participant and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent Female participants of childbearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol. Male participants with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study. Male participants must not donate sperm during and for 90 days following their participation in the study. Key Exclusion Criteria: Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents that has resulted in > 2% weight loss. Use of any medication that is approved to treat obesity within three months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion). Gastric bypass surgery within the previous six months or any prior gastric bypass surgery resulting in >10% weight loss durably maintained Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s) Suicidal ideation, attempt or behavior Clinically significant pulmonary, cardiac, or oncologic disease hemoglobin A1c (HbA1c) > 9.0% at Screening History of significant liver disease Glomerular filtration rate (GFR) < 30 milliliter/minute (mL/min) at Screening. History or close family history of melanoma or participant history of oculocutaneous albinism Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions. Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing. Participants previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide. Inability to comply with QD injection regimen. Females who are breastfeeding or nursing. Other protocol defined Inclusion/Exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Meeker, MD

Organizational Affiliation

Rhythm Pharmaceuticals, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Phoenix Southeast

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Honor Health Research Institute

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Axis Clinical Trials-Downtown

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Axis Clinical Trials Headquarters

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

San Diego Wake Research

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Division of Endocrinology and Diabetes Children's National Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

University of Florida College of Medicine

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

AXIS South Florida Clinical Trials

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

Florida Hospital

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - St. Petersburg

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60602

Country

United States

Facility Name

Maine Medical Partners

City

Portland

State/Province

Maine

ZIP/Postal Code

04102

Country

United States

Facility Name

NIH Hatfield Clinical Research Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Facility Name

Baystate Medical Center

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01107

Country

United States

Facility Name

University of Michigan Medicine

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Facility Name

Precision Medicine for Obesity Research: Gastroenterology & Hepatology Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Washington University St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Impact Clinical Trials

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

AXIS New York Clinical Trials

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

University at Buffalo

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Facility Name

AXIS Clinical Trials

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

Facility Name

Columbia University

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Wake Research Inc.

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Akron

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Columbus

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Obesity Institute, Geisinger Clinic

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Childrens Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Primary Care Associates, PC

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Wake Research TN

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Le Bonheur Children's Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Facility Name

Vanderbilt University School of Medicine

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212-3157

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - Plano

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Synexus Clinical Research US, Inc. - San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

Facility Name

Seattle Children's Research Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Marshfield Clinic Research Institute

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

University of Alberta

City

Edmonton

ZIP/Postal Code

T6G 2E1

Country

Canada

Facility Name

Hopital Trousseau - Nutrition et Gastroentérologie

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Hopital de la Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Service de pédiatrie CHU de la Réunion - Hôpital Félix Guyon

City

Saint-Denis

ZIP/Postal Code

97405

Country

France

Facility Name

Charité Berlin

City

Berlin

ZIP/Postal Code

13354

Country

Germany

Facility Name

University of Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

University of Ulm

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

University General Hospital of Patras

City

Río

State/Province

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

Edmond and Lily Safra Children's Hospital

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Erasmus MC

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Hospital Infantil Universitario Niño Jesús

City

Madrid

ZIP/Postal Code

65 28009

Country

Spain

Facility Name

University Hospitals Birmingham NHS Foundation Trust

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Addenbrooke's Hospital

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Hammersmith Hospital

City

London

ZIP/Postal Code

W12 0NN

Country

United Kingdom

Facility Name

Hammersmith Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35112343

Citation

Meyer JR, Krentz AD, Berg RL, Richardson JG, Pomeroy J, Hebbring SJ, Haws RM. Kidney failure in Bardet-Biedl syndrome. Clin Genet. 2022 Apr;101(4):429-441. doi: 10.1111/cge.14119.

Results Reference

derived

Learn more about this trial

Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

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