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Completed

NCT Number: NCT06041217

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

Drug

Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.

Placebo

Drug

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.

Primary outcomes

  1. Change in Body Weight (%)

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

    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)

    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

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

    Time frame: At end of treatment (week 44)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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.

  21. Change in Pulse

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

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

  22. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)

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

    Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: STEP12

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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