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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name STEP12

NCTNCT06041217 (opens ClinicalTrials.gov in a new tab)Other idNN9536-4706Other idU1111-1273-4538
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
242 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

China, Taiwan

Start
15 Sept 2023
Primary completion
2 Apr 2025
Completion
7 May 2025
First posted
18 Sept 2023
Last update posted
18 May 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    STEP12

    NCT06041217

    15 Sept 2023 to 7 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Semaglutide 2.4 milligram (mg)

    Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.

  • Placebo comparator

    Placebo

    Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Body Weight (%)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.

  2. Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

    Time frame · At end of treatment (week 44)

    Registry description

    Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.

Secondary outcomes(20)

  1. Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

    Time frame · At end of treatment (week 44)

    Registry description

    Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.

  2. Change in Waist Circumference

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented.

  3. Change in Body Weight (kg)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.

  4. Change in Body Mass Index

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.

  5. Change in Waist-height Ratio (WtHR)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.

  6. Change in Systolic Blood Pressure

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented.

  7. Change in Diastolic Blood Pressure

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented

  8. Change in Total Cholesterol (mmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  9. Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  10. Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  11. Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  12. Change in Triglycerides (mmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  13. Change in Free Fatty Acids (mmol/L) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  14. Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.

  15. Change in HbA1c (%)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.

  16. Change in HbA1c (mmol/Mol)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.

  17. Change in Fasting Plasma Glucose (mg/dL)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.

  18. Change in Fasting Plasma Glucose (mmol/L)

    Time frame · Baseline (week 0), end of treatment (week 44)

    Registry description

    Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.

  19. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame · From baseline (week 0) to end of study (week 49)

    Registry description

    Number of TEAEs from baseline (week 0) to end of study (week 49) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.

  20. Number of Serious Adverse Events (SAEs)

    Time frame · From baseline (week 0) to end of study (week 49)

    Registry description

    Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Body Weight (%)

GroupValue (Percentage change in body weight)Spread
Semaglutide 2.4 mg-12.28.2
Placebo-2.25.4
Primary outcomeCount of participants· At end of treatment (week 44)

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

GroupValue (Participants)
Semaglutide 2.4 mg128
Placebo19
Secondary and other outcome results(6)
Secondary outcomeCount of participants· At end of treatment (week 44)

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

GroupValue (Participants)
Semaglutide 2.4 mg96
Placebo9
Secondary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Waist Circumference

GroupValue (Centimeter (cm))Spread
Semaglutide 2.4 mg-9.16.2
Placebo-2.45.0
Secondary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Body Weight (kg)

GroupValue (Kg)Spread
Semaglutide 2.4 mg-9.36.1
Placebo-1.74.3
Secondary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Body Mass Index

GroupValue (Kilogram per square meter (kg/m^2))Spread
Semaglutide 2.4 mg-3.42.3
Placebo-0.61.5
Secondary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Waist-height Ratio (WtHR)

GroupValue (Ratio of waist-height)Spread
Semaglutide 2.4 mg-0.050.04
Placebo-0.010.03
Secondary outcomeMean· Baseline (week 0), end of treatment (week 44)

Change in Systolic Blood Pressure

GroupValue (Millimeter of mercury (mmHg))Spread
Semaglutide 2.4 mg-713
Placebo-410

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Sema 2.4 mgParticipants received subcutaneous (s.c.) injection of semaglutide once weekly in a dose escalation manner, with dose increasing every 4 weeks for up to week 16 (0.25, 0.5, 1.0, 1.7 and 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.0 / 16113 / 161113 / 161
PlaceboParticipants received placebo matched to semaglutide s.c. once weekly up to week 44 adjunct to a reduced calorie diet and increased physical activity.0 / 813 / 8126 / 81

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

4 results

Efficacy and safety of once-weekly semaglutide 2·4 mg in Chinese adults with overweight or obesity (STEP 12): a randomised, double-blind, placebo-controlled, multicentre, phase 3b trial.

Guo et al. 2026The lancet. Diabetes & endocrinologycited by 1

PMID 42575111DOI 10.1016/s2213-8587(26)00133-6PUB-42575111

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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