Clinical trial NCT05813925: A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity or Overweight
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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, α-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

Primary outcomes:
measure: Relative Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
Secondary outcomes:
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in VFA Measured by CT Scan in Subset of the Japanese Study Population
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: 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)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Relative Change in Body Weight
timeFrame: From baseline (week 0) to week 20
measure: Change in Body Weight
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Body Mass Index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Fasting Insulin
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Diastolic Blood Pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Total Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in High-Density Lipoprotein (HDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Low-Density Lipoprotein (LDL) Cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Very Low-Density Lipoprotein (VLDL)
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Free fatty Acids
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score
timeFrame: From baseline (week 0) to end of treatment (week 68)
measure: Number of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 75)
measure: Number of Serious Adverse Events (SAEs)
timeFrame: From baseline (week 0) to end of study (week 75)
Other outcomes:
Locations:
city: Koriyama-shi
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima, Japan
city: Yamato-shi
country: Japan
facility: Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Miyazaki-shi
country: Japan
facility: Heiwadai Hospital
state: Miyazaki
city: Suita-shi
country: Japan
facility: OCROM Clinic
state: Osaka
city: Yao-shi
country: Japan
facility: Yao Tokushukai General Hospital
state: Osaka
city: Aichi
country: Japan
facility: TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
city: Bunkyo-ku, Tokyo
country: Japan
facility: The University of Tokyo Hospital, Diabetes and Metabolic
city: Chiba-shi, Chiba
country: Japan
facility: Akaicho Clinic
city: Chiyoda-ku, Tokyo
country: Japan
facility: Suidoubashi Medical Clinic
city: Chuo-ku, Tokyo
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
city: Chuo-ku, Tokyo
country: Japan
facility: Okabe Clinic
city: Gunma
country: Japan
facility: Kawada Clinic
city: Ibaraki
country: Japan
facility: Naka Kinen Clinic
city: Iwate
country: Japan
facility: Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
city: Osaka
country: Japan
facility: Osaka NISHI-UMEDA Clinic
city: Sapporo-shi, Hokkaido
country: Japan
facility: Shinsapporo Seiryou Hospital, General Clinical Department
city: Sendai-shi, Miyagi
country: Japan
facility: Shinden Higashi Clinic
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: ToCROM Clinic
city: Tokyo
country: Japan
facility: Minamino Cardiovascular Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency' (dept. 2834)
role: STUDY_DIRECTOR
References: