A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
NCT ID: NCT06041217
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2023-09-15
2025-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Semaglutide 2.4 milligram (mg)
Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.
Semaglutide
Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
Placebo
Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.
Placebo
Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.
Interventions
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Semaglutide
Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
Placebo
Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital-Endocrinology
Fuzhou, Fujian, China
Huizhou Central People's Hospital-Endocrinology
Huizhou, Guangdong, China
Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
Hengshui, Hebei, China
Taihe Hospital-Endocrinology
Shiyan, Hubei, China
Changzhou No.2 People's Hospital, Yanghu Branch
Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
The First Bethune hospital of Jilin University-Endocrinology
Changchun, Jilin, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Fifth People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
Tongren Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital_main
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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U1111-1273-4538
Identifier Type: OTHER
Identifier Source: secondary_id
NN9536-4706
Identifier Type: -
Identifier Source: org_study_id
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