A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

Obesity Clinical Trial

— STEP12  

Official title:

Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041217
• Other study ID #: NN9536-4706
• Secondary ID: U1111-1273-4538
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2023
• Est. completion date: June 11, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: June 11, 2025
• Est. primary completion date: May 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	The first hospital of Jilin University	Changchun	Jilin
China	Changzhou No.2 People's Hospital, Yanghu Branch	Changzhou	Jiangsu
China	Chongqing University Three Gorges Hospital	ChongQing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Harrison International Peace Hospital	Hengshui
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	Jinan Central Hospital	Ji'nan	Shandong
China	The Second Affiliated Hospital of Nanjing Medical University_Nanjing	Nanjing	Jiangsu
China	Shanghai Fifth People's Hospital	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine	Shanghai	Shanghai
China	Taihe Hospital	Shiyan	Hubei
China	Qinghai Provincial People's Hospital	Xining	Qinghai
China	The Affiliated Hospital of Jiangsu University_Zhenjiang	Zhenjiang	Jiangsu
Taiwan	Ditmanson Medical Foundation Chia-Yi Christian Hospital	Chiayi City
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

China,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 44)
Primary	Body weight reduction = 5% (yes/no)	Measured as count of participants.	At end of treatment (week 44)
Secondary	Body weight reduction = 10% (yes/no)	Measured as count of participants.	At end of treatment (week 44)
Secondary	Change in waist circumference	Measured in centimeter.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in body weight	Measured in kilograms (kg).	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in body mass index	Measured in kilograms per square meter (kg/m^2).	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in total cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in high-density lipoprotein (HDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in low-density lipoprotein (LDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in very low-density lipoprotein (VLDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in triglycerides	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in free fatty acids	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in high-sensitivity c-reactive protein (hsCRP)	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in Glycated Haemoglobin (HbA1c) (Percent [%])	Measured in percentage point.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in HbA1c (mmol/mol)	Measured in millimoles per mole (mmol/mol).	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in fasting plasma glucose (mg/dL)	Measured in milligrams per deciliter (mg/dL).	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in fasting plasma glucose (mmol/L)	Measured in mmol/L	From baseline (week 0) to end of treatment (week 44)
Secondary	Number of Treatment-emergent Adverse Events (TEAEs)	Measured in count of events.	From baseline (week 0) to end of treatment (week 44)
Secondary	Number of Serious Adverse Events (SAEs)	Measured in count of events.	From baseline (week 0) to end of treatment (week 44)
Secondary	Change in pulse	Measured in beats per minute (bpm).	From baseline (week 0) to end of treatment (week 44)
Secondary	Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimole per liter [mmol/L]) confirmed by blood glucose [BG] meter)	Measured in number of episodes.	From baseline (week 0) to end of study (week 49)