| Outcome Measures: |
Primary: Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 48, Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated., Baseline, Week 48 | Secondary: Change From Baseline in Total Body Fat Mass by Dual Energy X-ray Absorptiometry (DXA) at Week 24, Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated., Baseline, Week 24|Change From Baseline in HbA1c at Week 24 and 48, HbA1c reflects average glucose concentrations over the past 3 months and therefore provides a useful index of the glycemic control of bimagrumab over that time period. It is a standard endpoint used to assess the glycemic efficacy of any anti-diabetic medication. HbA1c is a key glycemic parameter which correlates with reduction of risk of diabetic complications., Baseline, Week 24, Week 48|The Trough Observed Analyte Concentration (Ctrough) of Repeat Doses of BYM338 10 mg/kg on Day 84, 168, 252, 308 and 336, The trough observed analyte concentration (Ctrough) is the concentration that is just prior to the beginning of, or at the end of, a dosing interval (μg/mL)., Day 84, 252, 336 at pre-dose only. Day 168, 308 at pre-dose and 45 mins post-dose|Maximum Observed Serum Concentration(Cmax) Derived on Day 1, 168 and 308, Cmax is the observed maximum plasma concentration following administration (μg/mL)., Day 1, 168, 308 at pre-dose and 45 mins post-dose|Time to Reach the Maximum Concentration After Drug Administration (Tmax) Derived on Day 168 and 308, Tmax is the time to reach peak or maximum concentration (h) after the drug administration., Day 1, 168, 308 at pre-dose and 45 mins post-dose|Change From Baseline in Body Mass Index (BMI), Body Mass Index (BMI) was determined by height and weight measurements at week 24 and 48. A negative change from baseline indicates improvement. BMI was calculated as (Body weight (kg)/ \[Height (m)\]\^2), Baseline, Week 24, Week 48|Change From Baseline in Weight, Body weight was measured to the nearest 0.1 kilogram (kg) in indoor clothing without shoes. A negative change from baseline indicates improvement., Baseline, Week 24, Week 48|Change From Baseline in Lean Body Mass (LBM) Measured by DXA, Lean body mass (LBM) is a part of body composition defined as the difference between total body weight and body fat weight. This means that it counts the mass of all organs except body fat, including bones, muscles, blood, skin, and everything else. Dual energy X-ray absorptiometry (DXA) was used to assess changes in body composition, including total fat and lean body mass (FM and LBM) and appendicular skeletal fat and muscle mass (aFM and aLBM). DXA instruments had a source that generated x-rays split into two energies which measured bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) were estimated., Baseline, Week 24, Week 48|Change From Baseline in Waist Circumference, Waist circumference is the length in cm of the circumference to the nearest 0.1 cm at the level of the umbilicus with the subject in the upright position. A negative change indicates improvement., Baseline, Week 24, Week 52|Change From Baseline in Waist to Hip Ratio, Hip circumference was measured at the greatest protrusion of the buttocks. Combined with waist circumference, the waist-to-hip ratio was derived during data analysis., Baseline, Week 24, Week 52|Change From Baseline in Insulin Resistance (HOMA2-IR), Blood samples were collected to analyze insulin resistance. The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). Higher numbers indicate higher insulin resistance. No established cutoffs are indicating impaired resistance. HOMA2-IR was calculated using an online calculator \[https://www.dtu.ox.ac.uk/homacalculator/\]., Baseline. Week 12, Week 36|Immunogenicity Assessed by the Number of Participants Developing Anti-BYM338 Antibodies During the Trial, Describes the number of participants tested positive for anti-BYM338 antibodies after the start of bimagrumab (BYM338) treatment. A validated bridging enzyme-linked immunosorbent assay (ELISA) was used for the confirmation of the presence of anti-BYM338 antibodies in human serum., 392 days
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| Locations: |
Novartis Investigative Site, Anaheim, California, 92801, United States|Novartis Investigative Site, Miami Lakes, Florida, 33014, United States|Novartis Investigative Site, Miami, Florida, 33126, United States|Novartis Investigative Site, Miami, Florida, 33143, United States|Novartis Investigative Site, Orlando, Florida, 32804, United States|Novartis Investigative Site, Baton Rouge, Louisiana, 70808, United States|Novartis Investigative Site, Berlin, New Jersey, 08009, United States|Novartis Investigative Site, Eatontown, New Jersey, 07724, United States|Novartis Investigative Site, Merthyr Tydfil, Mid Glamorgan, CF484DR, United Kingdom
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