Trial · NCT03400163
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | From Day 1 to Day 112 | The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement. |
| Primary | Number of Participants With Adverse Events (AEs) | From first dose to date of last dose plus 30 days | The number of participants with on-study AEs was reported for each arm. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | From first dose to date of last dose plus 30 days | The number of participants with on-study SAEs was reported for each arm. |
| Primary | Number of Participants With Injection Site Reactions | From first dose to date of last dose plus 30 days | The number of participants with on-study injection site reactions was reported for each arm. |
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | From first dose to date of last dose plus 30 days | The number of participants with on-study AEs leading to discontinuation was reported for each arm. |
| Primary | Number of Deaths | From first dose to date of last dose plus 30 days | The number of deaths was reported for each arm. |
| Primary | Number of Participants With Marked Laboratory Abnormalities | From first dose to date of last dose plus 30 days | The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm. |
| Primary | Number of Participants With Vital Sign Abnormalities | From first dose to date of last dose plus 30 days | The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm. |
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | From first dose to date of last dose plus 30 days | The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm. |
| Primary | Number of Participants With Physical Examination Abnormalities | From first dose to date of last dose plus 30 days | The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm. |
| Primary | Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA) | From Day 1 to Day 112 | The mean percent change in bone mineral density from baseline to day 112 reported for each arm. |
| Secondary | Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112 | From Day 1 to Day 112 | The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm. |
| Secondary | Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142 | From Day 1 to Day 142 | Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm. |
| Secondary | Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142 | From Day 1 to Day 142 | Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03400163/registered