Study Summary
This trial will test whether a GLP-1 agonist or a dietary intervention can help girls with obesity and PCOS lower hepatic fat and improve insulin sensitivity.
Eligible Conditions
- Polycystic Ovarian Syndrome
- Non-Alcoholic Fatty Liver Disease
- Adolescent Obesity
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Baseline and 12 weeks
Baseline and 12 weeks
Insulin
Change in Hepatic Fat Fraction
Change in Rate of De Novo Lipogenesis
Change in Whole Body Insulin Sensitivity
Evaluation of Mitochondrial function via change in ratios of direct to indirect hepatic carbon flux in newly synthesized triglycerides
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Diet Intervention
1 of 2
GLP-1 Intervention
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Semaglutide 3mg and 7mg [Rybelsus] · No Placebo Group · Phase 2 & 3
GLP-1 Intervention
Drug
Experimental Group · 1 Intervention: Semaglutide 3mg and 7mg [Rybelsus] · Intervention Types: DrugDiet Intervention
Other
ActiveComparator Group · 1 Intervention: Weight loss diet · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 12 weeks
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,590 Previous Clinical Trials
1,927,128 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,141 Previous Clinical Trials
4,064,425 Total Patients Enrolled
Melanie Cree-Green, MD, PhDPrincipal InvestigatorChildren's Hospital Colorado
3 Previous Clinical Trials
71 Total Patients Enrolled
Eligibility Criteria
Age 12 - 21 · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:)
The NIH has adapted their criteria for PCOS to be more stringent when diagnosing the condition in adolescents
People participating in the study must not be taking hormonal contraceptives, and should either remain abstinent or use a non-hormonal form of contraception like a copper IUD
A person's BMI is above the 90th percentile for their age and gender if their BMI is equal to or greater than the value that corresponds to the 90th percentile for their age and gender.
A little more than 1 in 5 Americans are sedentary
Who else is applying?
What state do they live in?
| Colorado | 100.0% |
What site did they apply to?
| University of Colorado Anshutz Medical Campus/Children's Hospital Colorado | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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