Status:
COMPLETED
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 semaglutid...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2025
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT06041217
Start Date
September 15 2023
End Date
May 7 2025
Last Update
May 21 2025
Active Locations (20)
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1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
2
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China, 404000
3
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, China, 350001
4
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, China, 516001