STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

• Register: ClinicalTrials.gov
• Last refreshed on: 29 November 2021
• Main ID: NCT03548935
• Date of registration: 25/05/2018
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity STEP 1
• Scientific title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
• Date of first enrolment: June 4, 2018
• Target sample size: 1961
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03548935
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Japan, Mexico, Poland, Puerto Rico, Russian Federation, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Reporting Anchor and Disclosure (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

Main phase:

- Male or female, age greater than or equal to 18 years at the time of signing informed
consent

- Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to
27.0 kg/sqm with the presence of at least one of the following weight-related
comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep
apnoea or cardiovascular disease

- History of at least one self-reported unsuccessful dietary effort to lose body weight

Extension phase:

- Informed consent for the extension phase obtained before any trial related activities
for the extension phase

- On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg
semaglutide once-weekly or semaglutide placebo

Exclusion Criteria:

Main phase:

- Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured
by the central laboratory at screening

- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
screening irrespective of medical records

Extension phase:

- Female who is pregnant or intends to become pregnant during the extension phase

- Any disorder, unwillingness or inability, not covered by any of the other exclusion
criteria, which in the investigator's opinion, might jeopardise the subject's
compliance with the extension of the trial



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metabolism and Nutrition Disorder

Overweight or Obesity

Intervention(s)

Drug: Placebo (semaglutide)

Drug: Semaglutide

Primary Outcome(s)

Change in Body Weight (%) [Time Frame: Baseline (week 0) to week 68]

Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no) [Time Frame: After week 68]

Secondary Outcome(s)

Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score [Time Frame: After week 68]

Change in Body Composition (Visceral Fat Mass) (kg) [Time Frame: Baseline (week 0) to week 68]

Change in Body Weight (%) - DEXA Subpopulation [Time Frame: Baseline (week 0) to week 68]

Change in Free Fatty Acids (mg/dL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score [Time Frame: Baseline (week 0) to week 68]

Change in Systolic Blood Pressure (mmHg) [Time Frame: Baseline (week 0) to week 68]

Number of Serious Adverse Events (SAEs) [Time Frame: Baseline (week 0) to week 75]

Change in Amylase - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Leptin (ng/mL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Short Form 36 (SF-36) [Time Frame: Baseline (week 0) to week 68]

Change in Calcitonin - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Diastolic Blood Pressure (mmHg) [Time Frame: Baseline (week 0) to week 68]

Change in Body Composition (Lean Body Mass) (%) [Time Frame: Baseline (week 0) to week 68]

Change in Body Composition (Lean Body Mass) (kg) [Time Frame: Baseline (week 0) to week 68]

Change in Body Weight (kg) [Time Frame: Baseline (week 0) to week 68]

Change in Body Weight (kg) - DEXA Subpopulation [Time Frame: Baseline (week 0) to week 68]

Change in HbA1C (mmol/Mol) [Time Frame: Baseline (week 0) to week 68]

Change in Lipase - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score [Time Frame: After week 68]

Change in Body Composition (Total Fat Mass) (%) [Time Frame: Baseline (week 0) to week 68]

Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no) [Time Frame: Week 68]

Change in HbA1C (%) [Time Frame: Baseline (week 0) to week 68]

Change in Triglycerides (mg/dL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no) [Time Frame: Week 68]

Change in Body Composition (Total Fat Mass) (kg) [Time Frame: Baseline (week 0) to week 68]

Change in Body Mass Index (BMI) (kg/m2) [Time Frame: Baseline (week 0) to week 68]

Change in Body Composition (Visceral Fat Mass) (%) [Time Frame: Baseline (week 0) to week 68]

Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Fasting Plasma Glucose (FPG) (mg/dL) [Time Frame: Baseline (week 0) to week 68]

Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no) [Time Frame: Week 68]

Change in Pulse [Time Frame: Baseline (week 0) to week 68]

Change in Total Cholesterol (mg/dL) - Ratio to Baseline [Time Frame: Baseline (week 0) to week 68]

Number of Treatment Emergent Adverse Events (TEAEs) [Time Frame: Baseline (week 0) to week 75]

Change in Waist Circumference (cm) [Time Frame: Baseline (week 0) to week 68]

Secondary ID(s)

2017-003436-36

NN9536-4373

U1111-1200-8053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03548935