A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

Obesity or Overweight Clinical Trial

Official title:

Efficacy and Safety of Cagrilintide S.C. 2.4 mg in Combination With Semaglutide S.C. 2.4 mg (CagriSema S.C. 2.4 mg/2.4 mg) Once-Weekly in East Asian Participants With Overweight or Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813925
• Other study ID #: NN9838-4762
• Secondary ID: U1111-1277-3764j
• Status: Recruiting
• Phase: Phase 3
• Start date: April 3, 2023
• Est. completion date: March 17, 2025

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 17, 2025
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• Age greater than to or equal 18 years at the time of signing informed consent

• a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D

Diabetes-related for participant with T2D

• Diagnosed with T2D greater than or equal to 180 days before screening

• HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening

• Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, a-glucosidase inhibitors [AGI], glinides, sodium-glucose cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] as a single agent or in combination) according to local label

• Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

Exclusion Criteria:

Obesity-related

• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening

Glycaemia-related for participant without T2D

• HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening

• History of type 1 or type 2 diabetes

Diabetes-related for participant with T2D

• Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2) as measured by central laboratory at screening

• Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Related Conditions & MeSH terms

• Obesity
• Obesity or Overweight
• Overweight

Intervention

Drug:
• Cagrilintide
Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
• Semaglutide
Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
• Placebo Semaglutide
Participants will receive placebo matched to semaglutide

Locations

Country	Name	City	State
Japan	TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology	Aichi
Japan	The University of Tokyo Hospital, Diabetes and Metabolic	Bunkyo-ku, Tokyo
Japan	Akaicho Clinic	Chiba-shi, Chiba
Japan	Suidoubashi Medical Clinic	Chiyoda-ku, Tokyo
Japan	Okabe Clinic	Chuo-ku, Tokyo
Japan	The Institute of Medical Science, Asahi Life Foundation	Chuo-ku, Tokyo
Japan	Kawada Clinic	Gunma
Japan	Naka Kinen Clinic	Ibaraki
Japan	Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine	Iwate
Japan	Seino Internal Medicine Clinic	Koriyama-shi	Fukushima, Japan
Japan	Heiwadai Hospital	Miyazaki-shi	Miyazaki
Japan	AMC NISHI-UMEDA Clinic	Osaka
Japan	Shinsapporo Seiryou Hospital, General Clinical Department	Sapporo-shi, Hokkaido
Japan	Shinden Higashi Clinic	Sendai-shi, Miyagi
Japan	OCROM Clinic	Suita-shi	Osaka
Japan	Fukuwa Clinic	Tokyo
Japan	Minamino Cardiovascular Hospital	Tokyo
Japan	ToCROM Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa
Japan	Yao Tokushukai General Hospital	Yao-shi	Osaka
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Japan,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative Change in Body Weight	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline	Measured in centimeter (cm)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population	Measured as percentage point	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in VFA Measured by CT Scan in Subset of the Japanese Study Population	Measured in centimeter square (cm^2)	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Secondary	Relative Change in Body Weight	Measured in percentage (%)	From baseline (week 0) to week 20
Secondary	Change in Body Weight	Measured in kilogram (kg)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Body Mass Index (BMI)	Measured in kilogram per meter square (kg/m^2)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Glycated Haemoglobin (HbA1c)	Measured in percentage points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Fasting Plasma Glucose (FPG)	Measured as millimole per liter (mmol/L)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Fasting Insulin	Measured as milliunits per liter (mU/L)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Systolic Blood Pressure (SBP)	Measured in millimeter of mercury (mmHg)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Diastolic Blood Pressure (DBP)	Measured in millimeter of mercury (mmHg)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Total Cholesterol	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in High-Density Lipoprotein (HDL) Cholesterol	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Low-Density Lipoprotein (LDL) Cholesterol	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Very Low-Density Lipoprotein (VLDL)	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Triglycerides	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Free fatty Acids	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score	IWQOL-Lite-CT is a 20-item patient reported outcome (PRO) instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of Treatment-Emergent Adverse Events (TEAEs)	Measured as count of events	From baseline (week 0) to end of study (week 75)
Secondary	Number of Serious Adverse Events (SAEs)	Measured as count of events	From baseline (week 0) to end of study (week 75)