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

NCT05819853 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 21-4941R01HD108340
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Obese

Keywords

PCOS; semaglutide

Outcome Measures

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

  14 months

Secondary Outcomes (2)

• Change in Whole Body Insulin Sensitivity

  Baseline and 10 months

• Change in ovarian morphology

  Baseline and 10 months

Study Arms (2)

Untreated PCOS

EXPERIMENTAL

Participants with PCOS who are not on metformin or hormonal therapy, will receive 10-months of semaglutide intervention. Participants will get either semaglutide as either: Wegovy: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and 1.7mg for the remainder of the study. or Ozempic: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and Wegovy for 1.7mg for the remainder of the study.

Drug: Semaglutide Injectable Product (Wegovy and/or Ozempic)

PCOS on Metformin

EXPERIMENTAL

Participants with PCOS who are currently on metformin and still not having regular menses, will receive 10-months of semaglutide intervention. Participants in this arm will continue to take their metformin throughout the trial. Participants will get either semaglutide as either: Wegovy: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and 1.7mg for the remainder of the study. or Ozempic: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and Wegovy for 1.7mg for the remainder of the study.

Drug: Semaglutide Injectable Product (Wegovy and/or Ozempic)

Interventions

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

Also known as: Semaglutide (Wegovy and/or Ozempic)

PCOS on Metformin; Untreated PCOS

Eligibility Criteria

• Age: 12 Years - 35 Years
• Gender Eligibility Details: PCOS is a condition only found in those of female sex
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Initial BMI based on age and weight:
• If \<18 years, initial BMI percentile ≥95
• If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia
• Must be weight stable within ±5kg in the 3 months prior to enrollment
• Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia
• 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.
• For participants in the metformin + semaglutide group, participants must have been stable on ≥ 1500 mg of metformin a day for at least 3 months by time of screening

You may not qualify if:

• 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.
• Severe illness requiring hospitalization within 60 days.
• Diabetes, defined as Hemoglobin A1C ≥6.5%
• Anemia, defined as Hemoglobin \< 12 mg/dL
• Diagnosed major psychiatric or developmental disorder limiting informed consent.
• \) Known liver disease other than NAFLD, or AST or ALT \>125 IU/L. 11) Personal history of pancreatitis 12) Known renal disease of any severity or an eGFR at screening of \<45ml/min/1.73m2 13) History of severe GI disease (e.g., gastroparesis) 14) History of gallstones 15) Untreated thyroid disease 16) History of hypersensitivity to semaglutide 17) Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma).
• \) Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder 19) Desiring pregnancy in the next 12-18 months. 20) Bariatric surgery 21) Use of THC (smoking or edible) more than 3 days a week 22) Alcohol use-drinking more than 2 drinks, more than 3 days a week 23) Any potential participants who cannot/will not commit to abstinence, use of a copper intrauterine device (IUD), or use of double barrier forms of contraception.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Colorado Anschutz/Children's Hospital Colorado Aurora

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie Cree-Green, MD,PhD

  University of Colorado Anschutz/Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yesenia Garcia-Reyes, MS

CONTACT

720-777-6984; PCOSresearch@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: November 3, 2023
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)