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Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

ConditionsPCOS (Polycystic Ovary Syndrome) of Bilateral OvariesObese
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age12-35
SponsorUniversity of Colorado, Denver

About this trial

Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female

Ages 12-35 years

Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.

Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines

Disqualifiers

Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label

Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 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.

Weight loss medications in the last 6 months

Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Injectable Product (Wegovy and/or Ozempic)

    Drug

    10 months of semaglutide, with dose escalation as recommended by manufacturer. Maximum dose used will be 1.7mg

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Untreated PCOSExperimental treatment 1 intervention
Group B: PCOS on MetforminExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in ovulation frequency before and after semaglutide in females with PCOS

The change in ovulation will be measured at baseline and 6-10 months post treatment with semaglutide from 4 months daily urinary progesterone metabolites

Time frame
14 months

Secondary outcomes

1

Change in Whole Body Insulin Sensitivity

Participants will undergo a 75 gram oral glucose tolerance test, and whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model using SAMM II software. This software uses participant weight, glucose and insulin concentrations at various time points during the oral glucose tolerance test to calculate the participant's insulin sensitivity. A positive Si value means an improvement in insulin sensitivity.

Time frame
Baseline and 10 months
2

Change in ovarian morphology

Participants will have an ovarian ultrasound performed to measure change in ovarian morphology: ovarian size and number of follicles pre/post treatment with semaglutide

Time frame
Baseline and 10 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
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