A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
- Registration Number
- NCT06041217
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 162
- Age greater than or equal to 18 years at the time of signing informed consent.
- Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m^2, with or without weight related complications at screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
For participants with T2D at screening:
- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
Treated with either:
- Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.
- Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening
- Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory at screening.
- A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records.
- Treatment with any medication for the indication of obesity within the past 90 days before screening.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
For participants without T2D at screening:
- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.
For participants with T2D at screening:
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks. Semaglutide 2.4 milligram (mg) Semaglutide Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 44) Measured in percentage (%).
Body weight reduction ≥ 5% (yes/no) At end of treatment (week 44) Measured as count of participants.
- Secondary Outcome Measures
Name Time Method Body weight reduction ≥ 10% (yes/no) At end of treatment (week 44) Measured as count of participants.
Change in waist circumference From baseline (week 0) to end of treatment (week 44) Measured in centimeter.
Change in body weight From baseline (week 0) to end of treatment (week 44) Measured in kilograms (kg).
Change in body mass index From baseline (week 0) to end of treatment (week 44) Measured in kilograms per square meter (kg/m\^2).
Change in waist-height ratio (WtHR) From baseline (week 0) to end of treatment (week 44) Change in Glycated Haemoglobin (HbA1c) (Percent [%]) From baseline (week 0) to end of treatment (week 44) Measured in percentage point.
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 44) Measured in millimeters of mercury (mmHg).
Change in diastolic blood pressure From baseline (week 0) to end of treatment (week 44) Measured in mmHg.
Change in low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in very low-density lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in triglycerides From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in free fatty acids From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in high-sensitivity c-reactive protein (hsCRP) From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in total cholesterol From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in high-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 44) Measured in ratio to baseline.
Change in HbA1c (mmol/mol) From baseline (week 0) to end of treatment (week 44) Measured in millimoles per mole (mmol/mol).
Change in fasting plasma glucose (mg/dL) From baseline (week 0) to end of treatment (week 44) Measured in milligrams per deciliter (mg/dL).
Change in fasting plasma glucose (mmol/L) From baseline (week 0) to end of treatment (week 44) Measured in mmol/L
Number of Treatment-emergent Adverse Events (TEAEs) From baseline (week 0) to end of treatment (week 44) Measured in count of events.
Number of Serious Adverse Events (SAEs) From baseline (week 0) to end of treatment (week 44) Measured in count of events.
Change in pulse From baseline (week 0) to end of treatment (week 44) Measured in beats per minute (bpm).
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimole per liter [mmol/L]) confirmed by blood glucose [BG] meter) From baseline (week 0) to end of study (week 49) Measured in number of episodes.
Trial Locations
- Locations (20)
Ditmanson Medical Foundation Chia-Yi Christian Hospital
🇨🇳Chiayi City, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Fujian Medical University Union Hospital-Endocrinology
🇨🇳Fuzhou, Fujian, China
Huizhou Central People's Hospital-Endocrinology
🇨🇳Huizhou, Guangdong, China
Shanghai Fifth People's Hospital-Endocrinology
🇨🇳Shanghai, Shanghai, China
Shanghai Pudong New Area People's Hospital-Endocrinology
🇨🇳Shanghai, Shanghai, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Three Gorges Hospital
🇨🇳ChongQing, Chongqing, China
Taihe Hospital
🇨🇳Shiyan, Hubei, China
Changzhou No.2 People's Hospital, Yanghu Branch
🇨🇳Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University_Zhenjiang
🇨🇳Zhenjiang, Jiangsu, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
Qinghai Provincial People's Hospital
🇨🇳Xining, Qinghai, China
Jinan Central Hospital
🇨🇳Ji'nan, Shandong, China
Shanghai Fifth People's Hospital
🇨🇳Shanghai, Shanghai, China
National Cheng Kung University Hospital
🇨🇳Tainan City, Taiwan
Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
🇨🇳Shanghai, Shanghai, China
Taipei Medical University Hospital
🇨🇳Taipei city, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan