Semaglutide 3mg and 7mg [Rybelsus] for Polycystic Ovarian Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Polycystic Ovarian Syndrome+2 MoreSemaglutide 3mg and 7mg [Rybelsus] - Drug
Eligibility
12 - 21
Female
What conditions do you have?
Select

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

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

2 of 3
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: Drug
Diet Intervention
Other
ActiveComparator Group · 1 Intervention: Weight loss diet · Intervention Types: Other

Trial 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?
Colorado100.0%
What site did they apply to?
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%