Obesity
Conditions
Brief summary
Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant.
Detailed description
Maintenance of improved BMI category. From 1.5 years to 3 years and end of continued treatment phase (up to 6 years). Count of participant., Tapering to zero dose. From 1.5 years to 3 years. Count of participant., Time/dose steps before ending dose tapering. From 1.5 years to 3 years. Weeks, count of dose steps., Achieving BMI below obesity threshold. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Count of participant., Achieving any improvement in BMI category. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Count of participant., Change in BMI. From baseline (day 0) to 1.5 and 3 years. Percent., BMI percentage of the 95th percentile. From baseline (day 0) to 1.5 and 3 years. Percent., Change in BMI SDS. From baseline (day 0) to 1.5 and 3 years. Unitless., Change in waist-to-height ratio (waist [cm]/ height [cm]). From baseline (day 0) to 1.5 and 3 years. Unitless., Change in waist circumference. From baseline (day 0) to 1.5 and 3 years. Cm., Change in HbA1c. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Percentage points., Change in fasting plasma glucose. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). mmol/L, mg/dL., Change in fasting insulin and HOMA-IR. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent., Change in hsCRP. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent., Change in ALT, total cholesterol, HDL, LDL, VLDL and triglycerides. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Percent., Change in systolic and diastolic blood pressure. From baseline (day 0) to 1.5 and 3 years and end of continued treatment phase (up to 6 years). mmHg., Change in fat mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points., Change in lean body mass, by DXA relative to total body mass. From baseline (day 0) to 1.5 and 3 years. Percentage points., Relative change in visceral fat mass by DXA. From baseline (day 0) to 1.5 and 3 years. Percent., SAEs. From baseline (day 0) to 1.5 years, from 1.5 to 3 years, and from 3 years to end of continued treatment phase (up to 6 years). Count.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of BMI below obesity threshold. From 1.5 years to 3 years. Count of participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of improved BMI category. From 1.5 years to 3 years and end of continued treatment phase (up to 6 years). Count of participant., Tapering to zero dose. From 1.5 years to 3 years. Count of participant., Time/dose steps before ending dose tapering. From 1.5 years to 3 years. Weeks, count of dose steps., Achieving BMI below obesity threshold. From baseline (day 0) to 1.5, 3 years and end of continued treatment phase (up to 6 years). Count of participant., Achieving any improvement in BMI category. From baseline (day 0) to 1.5, 3 years, and end of continued treatment phase (up to 6 years). Count of participant., Change in BMI. From baseline (day 0) to 1.5 and 3 years. Percent., BMI percentage of the 95th percentile. From baseline (day 0) to 1.5 and 3 years. Percent., Change in BMI SDS. From baseline (day 0) to 1.5 and 3 years. Unitless., Change in waist-to-height ratio (waist [cm]/ height [cm]). From baseline (day 0) to 1.5 and 3 years. Unitless., Change in waist circumference. | — |
Countries
Belgium, Denmark, France, Germany, Greece, Italy, Poland, Sweden