Open-Label Study of Setmelanotide in Hypothalamic Obesity
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|ClinicalTrials.gov Identifier: NCT04725240|
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : November 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hypothalamic Obesity||Drug: Setmelanotide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label 20-Week Study to Evaluate the Safety and Efficacy of Setmelanotide in Subjects With Hypothalamic Obesity|
|Actual Study Start Date :||June 7, 2021|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Dosage: 1.0, 2.0, 3.0 mg daily for patients 6 to <16 years of age, and 2.0 to 3.0 mg daily for patients ≥16 years of age. All patients will receive study treatment for 16 weeks.
Investigational product: Setmelanotide for Subcutaneous (SC) injection.
- Change in Body Weight Related Measure [ Time Frame: 16 weeks ]Proportion of patients with ≥5% reduction from baseline in BMI after 16 weeks of setmelanotide treatment compared to a historic control of <5% in this patient population.
- Change in body weight related composite measures [ Time Frame: 16 weeks ]Composite proportion of patients aged ≥6 to <18 years with ≥0.2 reduction of BMI Z-score and patients aged ≥18 years with 5% reduction of body weight from baseline after 16 weeks of setmelanotide.
- Change in body weight related measure in children and adolescents [ Time Frame: 16 weeks ]Proportion of patients aged ≥6 to <18 years with ≥0.2 reduction of BMI Z-score from baseline after 16 weeks of setmelanotide.
- Change in body weight related measure in adults [ Time Frame: 16 weeks ]Proportion of patients aged ≥18 years with ≥5% reduction of body weight from baseline after 16 weeks of 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): NCT04725240
|Contact: Sarah Pilley, BS/MSfirstname.lastname@example.org|
|Contact: Emma Jost-Price, BAemail@example.com|
|United States, California|
|Rady Children's Hospital||Recruiting|
|San Diego, California, United States, 92123|
|Contact: Marla Hashiguchi 858-966-8940 firstname.lastname@example.org|
|Principal Investigator: Michael Gottschalk, MD|
|United States, Florida|
|University of Florida||Not yet recruiting|
|Gainesville, Florida, United States, 32610-0296|
|Contact: Rebeccah Mercado 407-383-8919 email@example.com|
|Principal Investigator: Jennifer Miller, MD|
|United States, Minnesota|
|Saint Paul, Minnesota, United States, 55102|
|Contact: Brittany Machus 651-220-5730 firstname.lastname@example.org|
|Principal Investigator: Jennifer Abuzzahab, MD|
|United States, Tennessee|
|Vanderbilt University School of Medicine||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Laura Maynard 615-875-4274 email@example.com|
|Principal Investigator: Ashley Shoemaker, MD|
|United States, Washington|
|Seattle Children's Research Institute||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: Sue Kearns 206-987-1758 firstname.lastname@example.org|
|Principal Investigator: Christian Roth, MD|
|Study Chair:||Linda Shapiro, MD, PhD||Rhythm Pharmaceuticals, Inc.|