Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03746522|
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bardet Biedl Syndrome (BBS) Alström Syndrome (AS)||Drug: Setmelanotide Drug: Placebos||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity|
|Estimated Study Start Date :||December 10, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Dosage form: Subcutaneous injection Dosage: 3 mg Frequency: daily
Setmelanotide is a peptide that binds to the human MC4 receptor.
Other Name: SET
Placebo Comparator: Placebo
Dosage form: Subcutaneous injection Dosage: 3 mg equivalent volume Frequency: daily
Matching placebo at equivalent volume to 3 mg setmelanotide.
- Effect of Setmelanotide [ Time Frame: 52 weeks ]The proportion of patients (greater than or equal to 12 years of age at baseline) who achieve a greater than or equal to 10% reduction from baseline in body weight (ie, are 'responders') after ~52 weeks of treatment with setmelanotide.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746522
|Contact: Matthew Websteremail@example.com|
|United States, Wisconsin|
|Marshfield Clinic Research Foundation||Recruiting|
|Marshfield, Wisconsin, United States, 54449|
|Contact: Allie Ott 715-389-4467 firstname.lastname@example.org|
|Contact: Brandi Fox 715-221-6121 email@example.com|
|Principal Investigator: Robert Haws|
|Study Chair:||Murray Stewart, MD||Rhythm Pharmceuticals, Inc|