A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Resumen

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Elegibilidad

Diseño del estudio

Variables de resultado

1. Variable de resultado principal

   Relative change in body weight

   Measured as percentage (%).

   Plazo From randomisation (week 0) to end of treatment (week 72)

2. Variable de resultado secundaria

   Relative change in body weight

   Measured as %.

   Plazo From randomisation (week 0) to end of treatment (week 72)

3. Variable de resultado secundaria

   Change in Body Mass Index (BMI)

   Measured as kilograms per square metre (kg/m\^2).

   Plazo From randomisation (week 0) to end of treatment (week 72)

4. Variable de resultado secundaria

   Number of participants who achieve greater than or equal to (≥) 30% weight reduction

   Measured as count of participants.

   Plazo From randomisation (week 0) to end of treatment (week 72)

5. Variable de resultado secundaria

   Number of participants who achieve ≥25% weight reduction

   Measured as count of participants.

   Plazo From randomisation (week 0) to end of treatment (week 72)

6. Variable de resultado secundaria

   Number of participants who achieve greater ≥ 20% weight reduction

   Measured as count of participants.

   Plazo From randomisation (week 0) to end of treatment (week 72)

7. Variable de resultado secundaria

   Change in waist circumference

   Measured in centimetre (cm).

   Plazo From randomisation (week 0) to end of treatment (week 72)

8. Variable de resultado secundaria

   Mean change in body weight

   Measured in kilograms (kg).

   Plazo From randomisation (week 0) to end of treatment (week 72)

9. Variable de resultado secundaria

   Number of participants who achieve a BMI less than (<) 30 kg/m^2

   Measured as count of participants.

   Plazo From randomisation (week 0) to end of treatment (week 72)

10. Variable de resultado secundaria

    Number of participants who achieve BMI <27 kg/m^2

    Measured as count of participants.

    Plazo end of treatment (week 72)

11. Variable de resultado secundaria

    Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2

    Measured as count of participants.

    Plazo At end of treatment (week 72)

12. Variable de resultado secundaria

    Number of participants who achieve a waist-to-height ratio < 0.53

    Measured as count of participants.

    Plazo At end of treatment (week 72)

13. Variable de resultado secundaria

    Ratio to baseline : Total cholesterol

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

14. Variable de resultado secundaria

    Ratio to baseline : High density lipoprotein (HDL) cholesterol

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

15. Variable de resultado secundaria

    Ratio to baseline : Low density lipoprotein (LDL) cholesterol

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

16. Variable de resultado secundaria

    Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

17. Variable de resultado secundaria

    Ratio to baseline : Triglycerides

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

18. Variable de resultado secundaria

    Ratio to baseline: Free fatty acids

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

19. Variable de resultado secundaria

    Ratio to baseline : Non-HDL cholesterol

    Measured in terms of ratio.

    Plazo From baseline (week 0) to end of treatment (week 72)

20. Variable de resultado secundaria

    Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function

    Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.

    Plazo From randomisation (week 0) to end of treatment (week 72)

21. Variable de resultado secundaria

    Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function

    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.

    Plazo From randomisation (week 0) to end of treatment (week 72)

22. Variable de resultado secundaria

    Change in glycated haemoglobin (HbA1c)

    Measured in %-points.

    Plazo From randomisation (week 0) to end of treatment (week 72)

23. Variable de resultado secundaria

    Number of participants who achieve HbA1c <6.5%

    Measured as count of participants.

    Plazo At end of treatment (week 72)

24. Variable de resultado secundaria

    Number of participants who achieve normal HbA1c <5.7%

    Measured as count of participants.

    Plazo At end of treatment (week 72)

25. Variable de resultado secundaria

    Number of treatment-emergent adverse events (TEAEs)

    Measured in number of events.

    Plazo From randomisation (week 0) to end of study (week 80)

26. Variable de resultado secundaria

    Number of treatment-emergent serious adverse events (TESAEs)

    Measured in number of events.

    Plazo From randomisation (week 0) to end of study (week 80)

Fechas

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

162 centros están en reclutamiento

En el registro figuran 253 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.