Clinical trial NCT06041217: A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
Official title: Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-09-18
Enrollment: 242
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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Body weight reduction ≥ 5% (yes/no)
timeFrame: At end of treatment (week 44)
Secondary outcomes:
measure: Body weight reduction ≥ 10% (yes/no)
timeFrame: At end of treatment (week 44)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in body mass index
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in waist-height ratio (WtHR)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in free fatty acids
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in high-sensitivity c-reactive protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in Glycated Haemoglobin (HbA1c) (Percent [%])
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in HbA1c (mmol/mol)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in fasting plasma glucose (mg/dL)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in fasting plasma glucose (mmol/L)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Number of Serious Adverse Events (SAEs)
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Change in pulse
timeFrame: From baseline (week 0) to end of treatment (week 44)
measure: Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimole per liter [mmol/L]) confirmed by blood glucose [BG] meter)
timeFrame: From baseline (week 0) to end of study (week 49)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
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: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital, Yanghu Branch
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University-Endocrinology
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune hospital of Jilin University-Endocrinology
state: Jilin
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital-Endocrinology
state: Shanghai
city: Shanghai
country: China
facility: Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital-Endocrinology
state: Shanghai
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei city
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: