Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity

Obesity Clinical Trial

— STEP 7  

Official title:

Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251156
• Other study ID #: NN9536-4379
• Secondary ID: U1111-1212-2189
• Status: Completed
• Phase: Phase 3
• Start date: December 8, 2020
• Est. completion date: September 18, 2022

Study information

• Verified date: June 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at the change in body weight from the start to the end of the study. The purpose of the study is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine participants will have talks with study staff about healthy food choices, how to be more physically active and what else they can do to lose weight. Participants will either get semaglutide or "dummy medicine" - which treatment is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm.• The study will last for about 1 year. Participants will have 11 clinic visits and 8 phone calls with the study doctor. Participants will have 3 clinic visits where they cannot eat and drink (water is allowed) for up to 8 hours before the visit and 1 clinic visit where they cannot eat and drink for up to 2 hours before the visit. (4 visits and 1 visit, respectively, if they have type 2 diabetes (T2D)). Participants will have 4 clinic visits where they will have blood samples taken. (5 visits if they have T2D). For China: Participants will have 9 clinic visits where they will have blood samples taken. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: September 18, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age 18 years or older at the time of signing informed consent

• History of at least one self-reported unsuccessful dietary effort to lose body weight

For subjects without T2D at screening:

• Body mass index (BMI) of :

• greater than or equal to 30 kg/m^2

• greater than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For subjects with T2D at screening:

• Diagnosed with T2D above or equal to 180 days prior to the day of screening

• Treated with either:

• diet and exercise alone or

• stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, a-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label

• HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

• BMI greater than or equal to 27 kg/m^2

Exclusion Criteria:

• A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

For subjects without T2D at screening:

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

For subjects with T2D at screening:

• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m^2 (below 60 mL/min/1.73 m^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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

• Diabetes Mellitus, Type 2
• Obesity
• Overweight

Intervention

Drug:
• Semaglutide
Semaglutide administered subcutaneously (s.c., under the skin) as well as diet and physical activity counselling for 44 weeks. Doses gradually increased to 2.4 mg
• Placebo (semaglutide)
Semaglutide placebo administered s.c. as an adjunct to a reduced-calorie diet and increased physical activity regimen for 44 weeks

Locations

Country	Name	City	State
Brazil	Novo Nordisk Investigational Site	Aparecida de Goiania	Goias
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
China	Novo Nordisk Investigational Site	Beijing	Beijing
China	Novo Nordisk Investigational Site	Beijing	Beijing
China	Novo Nordisk Investigational Site	Cangzhou	Hebei
China	Novo Nordisk Investigational Site	Changchun	Jilin
China	Novo Nordisk Investigational Site	Changzhou	Jiangsu
China	Novo Nordisk Investigational Site	ChongQing	Chongqing
China	Novo Nordisk Investigational Site	Fuzhou	Fujian
China	Novo Nordisk Investigational Site	Hengshui	Hebei
China	Novo Nordisk Investigational Site	Huhehaote	Inner Mongolia
China	Novo Nordisk Investigational Site	Huhhot	Inner Mongolia
China	Novo Nordisk Investigational Site	Jin'an	Shandong
China	Novo Nordisk Investigational Site	Kunming	Yunnan
China	Novo Nordisk Investigational Site	Nanjing	Jiangsu
China	Novo Nordisk Investigational Site	Nanjing	Jiangsu
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
China	Novo Nordisk Investigational Site	Shijiazhuang	Hebei
China	Novo Nordisk Investigational Site	Suzhou	Jiangsu
China	Novo Nordisk Investigational Site	Tianjin	Tianjin
China	Novo Nordisk Investigational Site	Tianjin	Tianjin
China	Novo Nordisk Investigational Site	Zhenjiang	Jiangsu
Hong Kong	Novo Nordisk Investigational Site	Shatin, New Territories
Korea, Republic of	Novo Nordisk Investigational Site	Gyeonggi-do
Korea, Republic of	Novo Nordisk Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Brazil,  China,  Hong Kong,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Percent	From baseline at week 0 to week 44
Primary	Subjects who achieve body weight reduction equal to or above 5% (yes/no)	Number of subjects	From baseline at week 0 to week 44
Secondary	Subjects who achieve body weight reduction equal to or above 10% (yes/no)	Number of subjects	From baseline at week 0 to week 44
Secondary	Subjects who achieve body weight reduction equal to or above 15% (yes/no)	Number of subjects	From baseline at week 0 to week 44
Secondary	Change in waist circumference	cm	From baseline at week 0 to week 44
Secondary	Change in systolic blood pressure	mmHg	From baseline at week 0 to week 44
Secondary	Change in physical functioning score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in physical function domain (5-items) score	The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.	From baseline at week 0 to week 44
Secondary	Change in body weight	kg	From baseline at week 0 to week 44
Secondary	Change in body mass index (BMI)	kg/m^2	From baseline at week 0 to week 44
Secondary	Change in glycosylated haemoglobin (HbA1c)	Percent	From baseline at week 0 to week 44
Secondary	Change in HbA1c	mmol /mol	From baseline at week 0 to week 44
Secondary	Change in fasting plasma glucose (FPG)	mg/dL	From baseline at week 0 to week 44
Secondary	Change in fasting serum insulin	mIU/L	From baseline at week 0 to week 44
Secondary	Change in diastolic blood pressure	mmHg	From baseline at week 0 to week 44
Secondary	Change in lipids: Total cholesterol	mg/dL	From baseline at week 0 to week 44
Secondary	Change in lipids: High density lipoprotein (HDL) cholesterol	mg/dL	From baseline at week 0 to week 44
Secondary	Change in lipids: Low density lipoprotein (LDL) cholesterol	mg/dL	From baseline at week 0 to week 44
Secondary	Change in lipids: Very low density lipoprotein (VLDL) cholesterol	mg/dL	From baseline at week 0 to week 44
Secondary	Change in lipids: Free fatty acids (FFA)	mg/dL	From baseline at week 0 to week 44
Secondary	Change in lipids: Triglycerides	mg/dL	From baseline at week 0 to week 44
Secondary	Change in SF-36: role-physical score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: bodily pain score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: general health score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: vitality score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: social functioning score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: role-emotional score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: mental health score	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: physical component summary	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in SF-36: mental component summary	Short Form 36 v2.0 acute (SF-36) is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health.	From baseline at week 0 to week 44
Secondary	Change in IWQoL-Lite for CT: pain/discomfort domain score	The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.	From baseline at week 0 to week 44
Secondary	Change in IWQoL-Lite for CT: psychosocial domain score	The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.	From baseline at week 0 to week 44
Secondary	Change in IWQoL-Lite for CT: total score	The Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQoL-Lite for CT) questionnaire is a 20-item modified version of an instrument designed to assess weight-related quality of life.	From baseline at week 0 to week 44
Secondary	Subjects who achieve responder definition value for SF-36 physical functioning score (yes/no)	Number of subjects	Week 44
Secondary	Subjects who achieve responder definition value for IWQoL-Lite for CT physical function domain (5-items) score (yes/no)	Number of subjects	Week 44
Secondary	Change in glycaemic category	Normo-glycaemia, pre-diabetes or T2D	From baseline at week 0 to week 44
Secondary	Change in antihypertensive medication	Decrease, no change, increase	From baseline at week 0 to week 44
Secondary	Change in lipid-lowering medication	Decrease, no change, increase	From baseline at week 0 to week 44
Secondary	Change in concomitant oral antidiabetic medication	Decrease, no change, increase (only applies to subjects with T2D at week 0)	From baseline at week 0 to week 44
Secondary	Change in fatty liver index (FLI) score category	Below 30, equal to or above 30 and below 60, equal to or above 60	From baseline at week 0 to week 44
Secondary	Subjects who have permanently discontinued randomised trial product (yes/no)	Number of subjects	From randomisation at week 0 to week 44
Secondary	Time to permanent discontinuation of randomised trial product	Weeks	Week 0 - week 44
Secondary	Number of treatment emergent adverse events (TEAEs)	Count	From week 0 to week 51
Secondary	Number of serious adverse events (SAEs)	Count	From week 0 to week 51
Secondary	Number of treatment emergent severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes (yes/no)	Count (only applies to subjects with T2D at week 0)	From week 0 to week 51
Secondary	Change in pulse	Beats per minute (bpm)	From baseline at week 0 to week 44
Secondary	Change in amylase	U/L	From baseline at week 0 to week 44
Secondary	Change in lipase	U/L	From baseline at week 0 to week 44
Secondary	Change in calcitonin	ng/L	From baseline at week 0 to week 44