Trial · NCT03919929
Treating PCOS With Semaglutide vs Active Lifestyle Intervention
NCT03919929, Phase 2, Phase 3, Completed, University of Colorado, Denver; results first posted 2025-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating PCOS With Semaglutide vs Active Lifestyle Intervention. Trials, record NCT03919929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03919929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating PCOS With Semaglutide vs Active Lifestyle Intervention
- NCT number
- NCT03919929
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- PCOS, Adolescent Obesity, NAFLD
- Interventions
- Semaglutide 3mg and 7mg [Rybelsus], Weight loss diet
- First posted
- 2019-04-18
- Last updated
- 2025-11-25
- Results first posted
- 2025-11-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hepatic Fat Fraction | 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%. A negative value means a decrease in liver fat, and a positive value means an increase in liver fat. |
| Primary | Change in Weight | Baseline and 12 weeks | Change in weight will be calculated for each group (diet and semaglutide), and both the absolute and relative weight changes between the two groups will be reported. |
| Secondary | Change in Rate of De Novo Lipogenesis (DNL) | Baseline and 12 weeks | Change from baseline of the rate of overnight de novo lipogenesis (DNL) will be measured utilizing stable isotope methods with deuterated water, and expressed as the rate of newly synthesized lipids in the serum triglyceride fraction. A negative value means a decrease in newly synthesized lipids after the 12 week intervention, and a positive value means an increase in newly synthesized lipids after the 12 week intervention. A lower value is better. |
| Secondary | Change in Whole Body Insulin Sensitivity | 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. |
| Secondary | Change in Adipose Insulin Sensitivity | 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. Percent suppression of FFAs during the OGTT was calculated as fasting FFA minus the minimal FFA value divided by fasting FFA. This was calculated for baseline and after 12-weeks of intervention. The change was calculated by subtracting the final-baseline values. A higher absolute value means there was an improvement in adipose insulin sensitivity after 12-weeks of treatment. |
| Other | Change in Percentage of Indirect Glycerol Carbon Contributions to Newly Synthesized Triglycerides and Glucose | Baseline and 12 weeks | This outcome evaluates mitochondrial function and excess tricarboxylic acid (TCA) cycle substrate cycling by measuring indirect carbon contributions to newly synthesized triglycerides and glucose using stable isotope-labeled glycerol. Participants receive orally administered \[U-13C3\]glycerol mixed in water, and plasma glucose and lipids are analyzed by 13C NMR spectroscopy. Indirect glycerol carbon contribution reflects the fraction of glycerol carbons that first enter the TCA cycle before incorporation into triglycerides and glucose. A decrease in the percentage of indirect contributions is beneficial, indicating decreased oxidative stress resulting from excess TCA cycling. |
| Other | Change in Free Androgen Index | Baseline and 12 weeks | The Free Androgen Index (FAI) is a test for hyperandrogenism in women, using testosterone and sex hormone binding globulin (SHBG) as markers. The calculation is FAI = Total Testosterone (nmol/ L)) x 100 / Sex Hormone-Binding Globulin (SHBG) (nmol/ L). Typical values for the FAI in women are 7-10, and FAI is usually elevated in women with PCOS. The change in FAI will be calculated after 12 weeks of diet or semaglutide intervention. A negative value means an improvement as there was a decrease in androgen levels after 12 weeks of treatment. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hepatic Fat Fraction | Baseline and 12 weeks | Change in percentage of liver fat | MEAN | |
| PRIMARY | Change in Weight | Baseline and 12 weeks | Change in weight (KG) | MEAN | |
| SECONDARY | Change in Rate of De Novo Lipogenesis (DNL) | Baseline and 12 weeks | mg/dL | MEAN | |
| SECONDARY | Change in Whole Body Insulin Sensitivity | Baseline and 12 weeks | dl/kg/min per microU/ml | MEAN | |
| SECONDARY | Change in Adipose Insulin Sensitivity | Baseline and 12 weeks | percentage of change | MEAN | |
| OTHER_PRE_SPECIFIED | Change in Percentage of Indirect Glycerol Carbon Contributions to Newly Synthesized Triglycerides and Glucose | Baseline and 12 weeks | percentage of indirect glycerol carbon c | MEAN | |
| OTHER_PRE_SPECIFIED | Change in Free Androgen Index | Baseline and 12 weeks | unitless | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hepatic Fat Fraction | Diet Intervention | -1.41 | Standard Deviation 2.24 | Change in percentage of liver fat | |
| Change in Hepatic Fat Fraction | GLP-1 Intervention | -1.84 | Standard Deviation 4.39 | Change in percentage of liver fat | |
| Change in Weight | Diet Intervention | -1.66 | Standard Deviation 2.81 | Change in weight (KG) | |
| Change in Weight | GLP-1 Intervention | -5.30 | Standard Deviation 4.92 | Change in weight (KG) | |
| Change in Rate of De Novo Lipogenesis (DNL) | Diet Intervention | 0.94 | Standard Deviation 5.7 | mg/dL | |
| Change in Rate of De Novo Lipogenesis (DNL) | GLP-1 Intervention | -1.9 | Standard Deviation 1.0 | mg/dL | |
| Change in Whole Body Insulin Sensitivity | Diet Intervention | 0.0000629 | Standard Deviation 0.000193 | dl/kg/min per microU/ml | |
| Change in Whole Body Insulin Sensitivity | GLP-1 Intervention | 0.000213 | Standard Deviation 0.000423 | dl/kg/min per microU/ml | |
| Change in Adipose Insulin Sensitivity | Diet Intervention | 0.44 | Standard Deviation 12.06 | percentage of change | |
| Change in Adipose Insulin Sensitivity | GLP-1 Intervention | -1.431 | Standard Deviation 9.97 | percentage of change |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diet Intervention | 17 | |
| Overall Study | STARTED | GLP-1 Intervention | 43 | |
| Overall Study | COMPLETED | Diet Intervention | 17 | |
| Overall Study | COMPLETED | GLP-1 Intervention | 34 | |
| Overall Study | NOT COMPLETED | Diet Intervention | 0 | |
| Overall Study | NOT COMPLETED | GLP-1 Intervention | 9 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diet Intervention | 0 | 17 |
| Total, all-cause mortality | GLP-1 Intervention | 0 | 38 |
| Total, other adverse events | Diet Intervention | 0 | 17 |
| Total, other adverse events | GLP-1 Intervention | 0 | 38 |
| Total, serious adverse events | Diet Intervention | 0 | 17 |
| Total, serious adverse events | GLP-1 Intervention | 0 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42014131 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK120612 | Impact of GLP-1 on Hepatic Fat and Energy Utilization in Obese Girls with Polycystic Ovarian Syndrome | CREE, MELANIE G | UNIVERSITY OF COLORADO DENVER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diet Intervention vs GLP-1 Intervention: deaths from any cause | Trial comparisons |
| Diet Intervention vs GLP-1 Intervention: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03919929
GET https://conductscience.org/api/trials/v1/NCT03919929/registered