Clinical trial NCT05996848: A Research Study to See How Well CagriSema Helps People in China 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 Chinese 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: 2023-08-18
Enrollment: 300
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 losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age above or equal to 18 years at the time of signing informed consent

  1. Body Mass Index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m\^2) or
  2. BMI greater than or equal to 27.0 kg/m\^2 with the presence of at least one weight-related comorbidity including, but not limited to, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:

* Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
* Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) 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 60 days before screening
* Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening

Exclusion Criteria:

For participants without T2D at screening:

* 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 mellitus

For participants with T2D at screening:

* Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
* 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 the central laboratory at screening
* 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: CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%
timeFrame: From baseline (week 0) to end of treatment (week 44)
Secondary outcomes:
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 51)
measure: CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From baseline (week 0) to end of study (week 51)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)
timeFrame: From baseline (week 0) to end of study (week 51)
measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)
timeFrame: From baseline (week 0) to end of study (week 51)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital-Endocrinology
state: Beijing
city: ChongQing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital-Endocrinology
state: Fujian
city: Huizhou
country: China
facility: Huizhou Central People's Hospital-Endocrinology
state: Guangdong
city: Hengshui
country: China
facility: Harrison International Peace Hospital-Endocrinology
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University-Endocrinology
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University-Endocrinology
state: Henan
city: Kaifeng
country: China
facility: Huaihe Hospital of Henan University
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan university of Science
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University-Endocrinology
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Changde
country: China
facility: The First People's Hospital of Changde City-Endocrinology
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital-Endocrinology
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University-Endocrinology
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Bethune hospital of Jilin University-Endocrinology
state: Jilin
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jin'an
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Minhang District-Endocrinology
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital-Endocrinology
state: Shanghai
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University-Endocrinology
state: Tianjin
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Jingan/Shanghai
country: China
facility: Huashan Hospital Fudan University
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Office (dept. 2834)
role: STUDY_DIRECTOR
References: