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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Treating PCOS With Semaglutide vs Active Lifestyle Intervention

Clinicaltrials.gov identifier NCT03919929

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted May 6, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:PCOS
    Adolescent Obesity
    NAFLD
  • Intervention/Treatment: Drug: Semaglutide 3mg and 7mg [Rybelsus]
    Other: Weight loss diet
  • Phase: Phase 2/Phase 3
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Treating PCOS With Semaglutide vs Active Lifestyle Intervention
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: July 2024
  • Estimated Study Completion Date: July 2024
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • Primary Outcome Measures: 1. Change in Hepatic Fat Fraction [ Time Frame: Baseline and 12 weeks ]
    Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%.
  • Secondary Outcome Measures: 1. Change in Whole Body Insulin Sensitivity [ Time Frame: Baseline and 12 weeks ]
    Participants will undergo a 75 gram oral glucose tolerance test, and the change from baseline in whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model.
  • 2. Change in Rate of De Novo Lipogenesis [ Time Frame: Baseline and 12 weeks ]
    Change from baseline of the rate of overnight de novo lipogenesis will be measured utilizing stable isotope methods with deuterated water, and expressed as the rate of newly synthesized lipids in the serum triglyceride fraction.
  • 3. Change in Adipose Insulin Sensitivity [ Time Frame: Baseline and 12 weeks ]
    Change from baseline of adipose insulin sensitivity will be calculated as the percent suppression of free fatty acids, and the nadir of free fatty acids during the oral glucose tolerance test.
  • Other Outcome Measures: 1. Evaluation of Mitochondrial function via change in ratios of direct to indirect hepatic carbon flux in newly synthesized triglycerides [ Time Frame: Baseline and 12 weeks ]
    OSTT with UC13 glycerol baseline and 12 weeks
Eligibility Criteria
  • Ages Eligible for Study: 12 to 21 Years (Child, Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

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
medication.

Exclusion Criteria:

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

Contacts and Locations
Contacts

Contact: Melanie Cree-Green, MD, PhD 720-777-5743 melanie.green@childrenscolorado.org

Contact: Yesenia Garcia-Reyes, MS 720-777-6984 yesenia.garciareyes@childrenscolorado.org

Locations

United States, Colorado
University of Colorado Anshutz Medical Campus/Children's Hospital Colorado
Aurora

Sponsors and Collaborators

University of Colorado, Denver

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Melanie Cree-Green, MD, PhD Children's Hospital Colorado

More Information
  • Responsible Party: University of Colorado, Denver
  • ClinicalTrials.gov Identifier: NCT03919929 History of Changes
  • Other Study ID Numbers: 19-0636, 1R01DK120612-01A1
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: May 6, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Colorado, Denver: Insulin Resistance
  • Additional relevant MeSH terms: Pediatric Obesity