A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range (STEP12)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• China
  • Hengshui, China, 053000
    • Withdrawn
    • Harrison International Peace Hospital
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Hospital
  • Chongqing
    • ChongQing, Chongqing, China, 404000
      • Recruiting
      • Chongqing University Three Gorges Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Huizhou, Guangdong, China, 516001
      • Recruiting
      • Huizhou Central People's Hospital
  • Hubei
    • Shiyan, Hubei, China, 442008
      • Recruiting
      • Taihe Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Recruiting
      • Changzhou No.2 People's Hospital, Yanghu Branch
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University_Nanjing
    • Zhenjiang, Jiangsu, China, 212001
      • Recruiting
      • The Affiliated Hospital of Jiangsu University_Zhenjiang
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Qinghai
    • Xining, Qinghai, China, 810007
      • Recruiting
      • Qinghai Provincial People's Hospital
  • Shandong
    • Ji'nan, Shandong, China, 250013
      • Recruiting
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200240
      • Recruiting
      • Shanghai Fifth People's Hospital
    • Shanghai, Shanghai, China, 200336
      • Recruiting
      • Tongren Hospital Shanghai Jiao Tong Univ. School of Medicine
    • Shanghai, Shanghai, China, 201200
      • Recruiting
      • Shanghai Pudong New Area People's Hospital
• Taiwan
  • Chiayi City, Taiwan, 600
    • Recruiting
    • Ditmanson Medical Foundation Chia-Yi Christian Hospital
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospital
  • Tainan City, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
  • Taipei city, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide 2.4 milligram (mg); Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.	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 Comparator: Placebo; Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 44)
Body weight reduction ≥ 5% (yes/no)	Measured as count of participants.	At end of treatment (week 44)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight reduction ≥ 10% (yes/no)	Measured as count of participants.	At end of treatment (week 44)
Change in waist circumference	Measured in centimeter.	From baseline (week 0) to end of treatment (week 44)
Change in body weight	Measured in kilograms (kg).	From baseline (week 0) to end of treatment (week 44)
Change in body mass index	Measured in kilograms per square meter (kg/m^2).	From baseline (week 0) to end of treatment (week 44)
Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 44)
Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 44)
Change in total cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in high-density lipoprotein (HDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in low-density lipoprotein (LDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in very low-density lipoprotein (VLDL) cholesterol	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in triglycerides	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in free fatty acids	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in high-sensitivity c-reactive protein (hsCRP)	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 44)
Change in Glycated Haemoglobin (HbA1c) (Percent [%])	Measured in percentage point.	From baseline (week 0) to end of treatment (week 44)
Change in HbA1c (mmol/mol)	Measured in millimoles per mole (mmol/mol).	From baseline (week 0) to end of treatment (week 44)
Change in fasting plasma glucose (mg/dL)	Measured in milligrams per deciliter (mg/dL).	From baseline (week 0) to end of treatment (week 44)
Change in fasting plasma glucose (mmol/L)	Measured in mmol/L	From baseline (week 0) to end of treatment (week 44)
Number of Treatment-emergent Adverse Events (TEAEs)	Measured in count of events.	From baseline (week 0) to end of treatment (week 44)
Number of Serious Adverse Events (SAEs)	Measured in count of events.	From baseline (week 0) to end of treatment (week 44)
Change in pulse	Measured in beats per minute (bpm).	From baseline (week 0) to end of treatment (week 44)
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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): May 7, 2025
• Study Completion (Estimated): June 11, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN9536-4706; U1111-1273-4538 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No