Trial · NCT05088460
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 in Fasting Serum Triglyceride (TG) (Cohort A) | Baseline to week 12 | Percentage change in fasting serum TG was reported for participants with elevated baseline fasting TG (\> 200 mg/dL) and with baseline leptin \< 8.0 ng/mL (Cohort A). |
| Primary | Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) (Cohort A) | Baseline to week 12 | Change in HbA1c was reported for participants with elevated baseline HbA1c (\> 7.0%) and with baseline leptin \< 8.0 ng/mL (Cohort A). |
| Secondary | Percent Change From Baseline to Week 12 in Fasting Serum TG (Cohorts B and A + B) | Baseline to week 12 | Percent change in fasting serum TG was reported for participants with elevated baseline fasting TG (\>200 mg/dL) in Cohort B and Cohorts A + B. |
| Secondary | Change From Baseline to Week 12 in HbA1c (Cohorts B and A + B) | Baseline to week 12 | Change in HbA1c was reported for participants with elevated baseline HbA1c (\>7.0%) in Cohort B and Cohorts A + B. |
| Secondary | Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 1) | Baseline, Week 12, Week 24 | Percent change in fasting serum TG was reported for participants in Study Arm 1. |
| Secondary | Percent Change From Baseline to Weeks 12 and 24 in Fasting Serum TG (Study Arm 2) | Baseline, Week 12, Week 24 | Percent change in fasting serum TG was reported for participants in Study Arm 2. |
| Secondary | Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 1) | Baseline, Week 12, Week 24 | Change from baseline in HbA1c was reported for participants in Study Arm 1. |
| Secondary | Change From Baseline to Weeks 12 and 24 in HbA1c (Study Arm 2) | Baseline, Week 12, Week 24 | Change from baseline in HbA1c was reported for participants in Study Arm 2. |
| Secondary | Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 1) | Baseline, Week 12, Week 24 | Change from baseline in fasting glucose was reported for participants in Study Arm 1. |
| Secondary | Change From Baseline to Weeks 12 and 24 in Fasting Glucose (Study Arm 2) | Baseline, Week 12, Week 24 | Change from baseline in fasting glucose was reported for participants in Study Arm 2. |
| Secondary | Percent Change From Baseline to Weeks 12 and 24 in Liver Fat Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) (Study Arm 1) | Baseline, Week 12, Week 24 | Percent change from baseline in MRI-PDFF was reported for participants with baseline MRI-PDFF ≥8.5% in Study Arm 1. |
| Secondary | Percent Change From Baseline to Weeks 12 and 24 in Liver Fat MRI-PDFF (Study Arm 2) | Baseline, Week 12, Week 24 | Percent change from baseline in MRI-PDFF was reported for participants with baseline liver fat MRI-PDFF ≥8.5% in Study Arm 2. |
| Secondary | Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Highest Hunger Score | Baseline, Week 12, Week 24 | The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The highest hunger score asked participants to rate their highest hunger that day on a scale from 0 to 4, with higher scores representing the higher perceived hunger. A negative change from baseline indicated a reduction in perceived hunger. |
| Secondary | Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Lowest Hunger Score | Baseline, Week 12, Week 24 | The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The lowest hunger score asked participants to rate their lowest hunger that day on a scale from 0 to 4, with higher scores indicating higher perceived hunger. A negative change from baseline score indicated a reduction in perceived lowest hunger. |
| Secondary | Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Felt Hungry Score | Baseline, Week 12, Week 24 | The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among participants with lipodystrophy. The felt hungry score asked how much time participants felt hunger that day on a scale from 0 to 4, with higher scores indicating more time feeling hungry. A negative change from baseline score indicated a reduction in time spent feeling hungry. |
| Secondary | Change From Baseline to Weeks 12 and 24 on the Daily Lipodystrophy Hunger Questionnaire - Fullness Score | Baseline, Week 12, Week 24 | The daily lipodystrophy hunger questionnaire was developed to assess hunger related behaviors among patients with lipodystrophy. The fullness score asked participants to rate how often they felt full after eating that day on a scale from 0 to 4, with higher scores indicating higher feeling of fullness. A negative change from baseline indicated a reduced feeling of fullness. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to Day 169 | |
| Secondary | Concentrations of REGN4461 in Serum | Weeks 0, 1, 2, 3, 4, 5, 6, 9, 12, 13, 14, 15, 16, 17, 18, 21, 28, 32 and 36. Weeks 0 and 12 collected pre- and post-dose. All other time points were only pre-dose. | |
| Secondary | Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) Response | Up to Day 281 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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