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Completed

NCT Number: NCT03693430

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 phone calls with the study doctor.

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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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Surrey, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, age more than or equal to 18 years at the time of signing informed consent
  • Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 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

Exclusion criteria

  • HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Treatment and study plan

semaglutide

Drug

Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Placebo (semaglutide)

Drug

S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks

Primary outcomes

  1. Percentage Change From Baseline (Week 0) to Week 104 in Body Weight

    Time frame: From Baseline (Week 0) to Week 104

    Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  2. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

    Time frame: At Week 104

    Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Secondary outcomes

  1. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

    Time frame: At Week 104

    Number of participants who achieved >=10% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  2. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

    Time frame: At Week 104

    Number of participants who achieved >=15% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  3. Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

    Time frame: At Week 104

    Number of participants who achieved >=20% weight loss at 104 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  4. Change From Baseline (Week 0) to Week 104 in Waist Circumference

    Time frame: From Baseline (Week 0) to Week 104

    Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  5. Change From Baseline (Week 0) to Week 104 in Body Weight (kg)

    Time frame: From Baseline (Week 0) to Week 104

    Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  6. Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)

    Time frame: From Baseline (Week 0) to Week 104

    Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  7. Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure

    Time frame: From Baseline (Week 0) to Week 104

    Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  8. Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure

    Time frame: From Baseline (Week 0) to Week 104

    Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  9. Change in Total Cholesterol-ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  10. Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  11. Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  12. Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  13. Change in Free Fatty Acids-ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  14. Change in Triglycerides-ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  15. Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

    Time frame: From Baseline (Week 0) to Week 104

    Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  16. Change in Glycated Haemoglobin (HbA1c) (Percent [%])

    Time frame: From Baseline (Week 0) to Week 104

    Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  17. Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)

    Time frame: From Baseline (Week 0) to Week 104

    Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  18. Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)

    Time frame: From Baseline (Week 0) to Week 104

    Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  19. Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)

    Time frame: From Baseline (Week 0) to Week 104

    Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  20. Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)

    Time frame: From Baseline (Week 0) to Week 104

    Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  21. Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)

    Time frame: From Baseline (Week 0) to Week 104

    Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.

  22. Percentage Change From Baseline (Week 0) to Week 52 in Body Weight

    Time frame: From Baseline (Week 0) to Week 52

    Percentage change in body weight from baseline (week 0) to week 52 is presented.

  23. Change From Baseline (Week 0) to Week 52 in Body Weight (kg)

    Time frame: From Baseline (Week 0) to Week 52

    Change in body weight from baseline (week 0) to week 52 in kg is presented.

  24. Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)

    Time frame: From Baseline (Week 0) to Week 52

    Change in BMI from baseline (week 0) to week 52 is presented.

  25. Change From Baseline (Week 0) to Week 52 in Waist Circumference

    Time frame: From Baseline (Week 0) to Week 52

    Change in waist circumference from baseline (week 0) to week 52 is presented.

  26. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%

    Time frame: At Week 52

    Number of participants who achieved >=5% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=5% weight loss, whereas 'No' infers the number of participants who have not achieved >=5% weight loss.

  27. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%

    Time frame: At Week 52

    Number of participants who achieved >=10% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=10% weight loss, whereas 'No' infers the number of participants who have not achieved >=10% weight loss.

  28. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%

    Time frame: At Week 52

    Number of participants who achieved >=15% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=15% weight loss, whereas 'No' infers the number of participants who have not achieved >=15% weight loss.

  29. Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%

    Time frame: At Week 52

    Number of participants who achieved >=20% weight loss at 52 weeks is presented. In the reported data, 'Yes' infers the number of participants who have achieved >=20% weight loss, whereas 'No' infers the number of participants who have not achieved >=20% weight loss.

  30. Number of Treatment-emergent Adverse Events (TEAEs)

    Time frame: From Baseline (Week 0) to Week 111

    An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).

  31. Number of Serious Adverse Events (SAEs)

    Time frame: From Baseline (Week 0) to Week 111

    A SAE was defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).

  32. Change From Baseline (Week 0) to Week 104 in Pulse

    Time frame: From Baseline (Week 0) to Week 104

    Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  33. Change From Baseline (Week 0) to Week 104 in Amylase

    Time frame: From Baseline (Week 0) to Week 104

    Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  34. Change From Baseline (Week 0) to Week 104 in Lipase

    Time frame: From Baseline (Week 0) to Week 104

    Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

  35. Change From Baseline (Week 0) to Week 104 in Calcitonin

    Time frame: From Baseline (Week 0) to Week 104

    Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

Acronym: STEP 5

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2018
Registry last updated
Jul 6, 2023

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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