Trial · NCT03005288
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48 | Baseline, Week 48 | Pharmacodynamic (PD) analysis set | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24 | Baseline, Week 24 | Pharmacodynamic analysis set | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in HbA1c at Week 24 and 48 | Baseline, Week 24, Week 48 | Pharmacodynamic analysis set | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336 | Day 84, 252, 336 at pre-dose only. Day 168, 308 at pre-dose and 45 mins post-dose | Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338 | μg/mL | MEAN |
| SECONDARY | Maximum Observed Serum Concentration(Cmax) Derived on Day 1, 168 and 308 | Day 1, 168, 308 at pre-dose and 45 mins post-dose | Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338 | μg/mL | MEAN |
| SECONDARY | Time to Reach the Maximum Concentration After Drug Administration (Tmax) Derived on Day 168 and 308 | Day 1, 168, 308 at pre-dose and 45 mins post-dose | Pharmacokinetics (PK) analysis set - PK samples were only obtained and evaluated for subjects treated with BYM338 | hr | MEDIAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) | Baseline, Week 24, Week 48 | Pharmacodynamic analysis set | Kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weight | Baseline, Week 24, Week 48 | Pharmacodynamic analysis set | Kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Lean Body Mass (LBM) Measured by DXA | Baseline, Week 24, Week 48 | Pharmacodynamic analysis set | Kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Waist Circumference | Baseline, Week 24, Week 52 | Pharmacodynamic analysis set | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Waist to Hip Ratio | Baseline, Week 24, Week 52 | Pharmacodynamic analysis set | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin Resistance (HOMA2-IR) | Baseline. Week 12, Week 36 | Pharmacodynamic analysis set | Insulin Resistance (IR) Score | LEAST_SQUARES_MEAN |
| SECONDARY | Immunogenicity Assessed by the Number of Participants Developing Anti-BYM338 Antibodies During the Trial | 392 days | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
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/NCT03005288/outcomes