Weight management with orismilast alone or in combination with s.c. semaglutide (WELOSITI)

Conditions

obesity

Brief summary

Percentage change in body weight from week 0 to week 16

Detailed description

Change in body weight in kilograms from week 0 to week 16, Body weight reduction ≥ 3% at week 16, Body weight reduction ≥ 5% at week 16, Body weight reduction ≥ 10% at week 16, change in high sensitivity CRP, change in IL-6, Change in TNF-alfa, Body weight reduction ≥ 15% at week 16, Change in BMI (kg/m2) from week 0 to 16, Change in waist-hip ratio from week 0, Change in waist circumference (cm) from week 0 to 16, Change in systolic and diastolic blood pressure (mmHg), Change in heart rate (beats per minute), Change in body composition (fat-free mass, total fat mass, visceral fat mass rating and bone mass) as measured by bioimpedance, Change in fasting serum/plasma concentrations of inflammatory biomarkers

Related papers

No related papers found yet.

Interventions

DRUGOrismilast

DRUGThe placebo tablets are identical in contents to the orismilast IMP

DRUGapart from that they do not contain the pharmaceutically active molecule. The pharmaceutically active molecule is replaced by lactose

DRUGSEMAGLUTIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change in body weight from week 0 to week 16	—

Secondary

Measure	Time frame
Change in body weight in kilograms from week 0 to week 16, Body weight reduction ≥ 3% at week 16, Body weight reduction ≥ 5% at week 16, Body weight reduction ≥ 10% at week 16, change in high sensitivity CRP, change in IL-6, Change in TNF-alfa, Body weight reduction ≥ 15% at week 16, Change in BMI (kg/m2) from week 0 to 16, Change in waist-hip ratio from week 0, Change in waist circumference (cm) from week 0 to 16, Change in systolic and diastolic blood pressure (mmHg), Change in heart rate (beats per minute), Change in body composition (fat-free mass, total fat mass, visceral fat mass rating and bone mass) as measured by bioimpedance, Change in fasting serum/plasma concentrations of inflammatory biomarkers	—

Measure

Time frame

Change in body weight in kilograms from week 0 to week 16, Body weight reduction ≥ 3% at week 16, Body weight reduction ≥ 5% at week 16, Body weight reduction ≥ 10% at week 16, change in high sensitivity CRP, change in IL-6, Change in TNF-alfa, Body weight reduction ≥ 15% at week 16, Change in BMI (kg/m2) from week 0 to 16, Change in waist-hip ratio from week 0, Change in waist circumference (cm) from week 0 to 16, Change in systolic and diastolic blood pressure (mmHg), Change in heart rate (beats per minute), Change in body composition (fat-free mass, total fat mass, visceral fat mass rating and bone mass) as measured by bioimpedance, Change in fasting serum/plasma concentrations of inflammatory biomarkers

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Countries

Denmark

Outcome results

None listed