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

Primary Purpose

Overweight, Obesity

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 greater than 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.

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational SiteRecruiting
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide 2.4 milligram (mg)

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Relative change in body weight
Measured in percentage (%).
Body weight reduction ≥ 5% (yes/no)
Measured as count of participants.

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2023
Last Updated
October 24, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT06041217
Brief Title
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
Acronym
STEP12
Official Title
Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
May 7, 2025 (Anticipated)
Study Completion Date
June 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 2.4 milligram (mg)
Arm Type
Experimental
Arm Description
Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Relative change in body weight
Description
Measured in percentage (%).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Body weight reduction ≥ 5% (yes/no)
Description
Measured as count of participants.
Time Frame
At end of treatment (week 44)
Secondary Outcome Measure Information:
Title
Body weight reduction ≥ 10% (yes/no)
Description
Measured as count of participants.
Time Frame
At end of treatment (week 44)
Title
Change in waist circumference
Description
Measured in centimeter.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in body weight
Description
Measured in kilograms (kg).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in body mass index
Description
Measured in kilograms per square meter (kg/m^2).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in systolic blood pressure
Description
Measured in millimeters of mercury (mmHg).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in diastolic blood pressure
Description
Measured in mmHg.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in total cholesterol
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in high-density lipoprotein (HDL) cholesterol
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in low-density lipoprotein (LDL) cholesterol
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in very low-density lipoprotein (VLDL) cholesterol
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in triglycerides
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in free fatty acids
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in high-sensitivity c-reactive protein (hsCRP)
Description
Measured in ratio to baseline.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in Glycated Haemoglobin (HbA1c) (Percent [%])
Description
Measured in percentage point.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in HbA1c (mmol/mol)
Description
Measured in millimoles per mole (mmol/mol).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in fasting plasma glucose (mg/dL)
Description
Measured in milligrams per deciliter (mg/dL).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in fasting plasma glucose (mmol/L)
Description
Measured in mmol/L
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Number of Treatment-emergent Adverse Events (TEAEs)
Description
Measured in count of events.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Number of Serious Adverse Events (SAEs)
Description
Measured in count of events.
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Change in pulse
Description
Measured in beats per minute (bpm).
Time Frame
From baseline (week 0) to end of treatment (week 44)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimole per liter [mmol/L]) confirmed by blood glucose [BG] meter)
Description
Measured in number of episodes.
Time Frame
From baseline (week 0) to end of study (week 49)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 greater than 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442008
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810007
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jin'an
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200240
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hengshui
ZIP/Postal Code
053000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chiayi City
ZIP/Postal Code
600
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taipei city
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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