- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919929
Recruitment Status Recruiting
First Posted April 18, 2019
Last update posted May 6, 2020
Girls with obesity and polycystic ovarian syndrome will receive either glucagon like peptide-1 receptor agonist therapy or a dietary intervention for 12 weeks to decrease the metabolic syndrome, in particular to lower hepatic fat and improve insulin sensitivity.
In obese girls with polycystic ovarian syndrome, testosterone and obesity combine to create unique pathology to increase metabolic disease including fatty liver and insulin resistance, which may be mediated by altered glucagon like peptide-1 activity. The investigators will treat girls with obesity and polycystic ovarian syndrome for 4 months with a glucagon like peptide-1 receptor agonist compared to dietary intervention to primarily lower hepatic fat and secondarily improve whole body and adipose insulin sensitivity. Mechanisms of hepatic metabolism, including rates of de novo lipogenesis and relative mitochondrial flux will also be assessed.
|Experimental: GLP-1 Intervention
Participants will take a daily oral tablet of semaglutide for 4 months.
Drug: Semaglutide 3mg and 7mg [Rybelsus]
Once daily oral tablet of semaglutide for 4 months
|Active Comparator: Diet Intervention
Weight loss with dietary intervention
Other: Weight loss diet
Prescribed weight loss diet to match weight loss in Drug arm
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
2. BMI equal or greater than the 90th percentile for age and gender
3. PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses >12
months post-menarche and clinical or biochemical hypertestosteronemia
4. Participants cannot be on hormonal contraception, so participants should remain
abstinent or use reliable non-hormonal contraception (e.g. copper IUD) for the entire
study period. For participants who receive semaglutide, they should avoid pregnancy
for at least 2 months after stopping medication to avoid fetal exposure to the
1. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or
Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Family history of medullary
thyroid cancer or thyroid nodule palpated by endocrinologist at screening.
2. Use of medications known to affect insulin sensitivity: metformin (cannot have been
used in the 3 months prior to screening), oral glucocorticoids within 10 days,
atypical antipsychotics, immunosuppressant agents, HIV medications, hormonal
contraception (cannot have been used in the 6 months prior to screening). Dermal patch
or vaginal ring contraception methods.Weight loss medications or stimulants. Use of
other products containing other GLP-1 agonists.
3. Currently pregnant or breastfeeding women. Development of pregnancy during the study
period will necessitate withdrawal from the study.
4. Severe illness requiring hospitalization within 60 days.
5. Diabetes, defined as Hemoglobin A1C > 6.4%
6. BMI percentile less than the 90th percentile for age and sex. Weight >325 lbs. or <84 lbs. 7. Anemia, defined as Hemoglobin 100 IU/L.
12. Personal history of pancreatitis
13. Known renal disease of any severity or an eGFR at screening of <45ml/min/1.73m2 14. History of severe GI disease (e.g. gastroparesis) 15. History of gallstones 16. Untreated thyroid disease 17. History of hypersensitivity to semaglutide 18. Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma). 19. Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder
Contact: Melanie Cree-Green, MD, PhD 720-777-5743 firstname.lastname@example.org
Contact: Yesenia Garcia-Reyes, MS 720-777-6984 email@example.com
United States, Colorado
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Melanie Cree-Green, MD, PhD Children's Hospital Colorado