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NCT03480022 · ClinicalTrials.gov registry record · Phase 3
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
A Phase 3 study, sponsored by Woman's.
- Completed
- Registry status
- Phase 3
- Development phase
- 88
- Enrollment target
NCT03480022 is a Phase 3 study that has completed, run by Woman's. The registered enrollment target is 88 participants.
The verdict
NCT03480022, a Phase 3 study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 88 participants
- Enrollment target
Study Summary
There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported in other studies can be confirmed in a selected population of hyperandrogenic patients, especially with medications currently approved for weight reduction. High dose liraglutide alone results in significant weight reduction in obese women without PCOS. There is limited data on weight loss with high dose liraglutide in non-diabetic females with PCOS treated with this agent . Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and androgen excess in obese women diagnosed with PCOS are lacking. The investigators aim to elucidate the most efficacious weight reduction regime in obese PCOS women. The investigators further hope to determine which treatment(s) addressing the multifaceted disturbances of this disorder in patients with PCOS and obesity emerges as the preferable therapy.
Interventions
- DRUG Liraglutide Pen Injector [Saxenda]
- DRUG Placebo Liraglutide Pen Injector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2018-09-26 |
| Est. Completion | 2021-05-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03480022
The ClinicalTrials.gov registry entry for NCT03480022 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liraglutide Pen Injector [Saxenda] is the first listed.
NCT03480022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03480022 about?
NCT03480022 is a clinical study titled "Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS". There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS). Given that PCOS is a frequent condition and weight loss is essential but difficult to achieve, it is important to study if the effect on body weight reported i...
What is the current status of trial NCT03480022?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2018-09-26. Estimated completion is 2021-05-19.
What interventions are being tested in trial NCT03480022?
The interventions under investigation include: Liraglutide Pen Injector [Saxenda] (DRUG), Placebo Liraglutide Pen Injector (DRUG).
Who is sponsoring clinical trial NCT03480022?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
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