Trial · Interventional

CompletedPhase 3Results postedRegistry data

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Short name STEP 10

NCTNCT05040971Other idNN9536-4734Other idU1111-1253-1956Other id2020-002939-29

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 207 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 5 countries
Canada, Denmark, Finland, Spain, United Kingdom
Start: 6 Sept 2021
Primary completion: 6 Jan 2023
Completion: 14 Jul 2023
First posted: 10 Sept 2021
Last update posted: 29 Jan 2026
Conditions: Obesity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2021202220232024

Ph 3
STEP 10
NCT05040971
6 Sept 2021 to 14 Jul 2023

Registry summary

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

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine. 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 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Interventions

Semaglutide 2.4 mgDrug
PlaceboDrug

Arms2

Experimental
Semaglutide
Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks
Placebo comparator
Placebo (semaglutide)
Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in Body Weight (Percentage [%])
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants With Change to Normoglycemia
Time frame · At week 52
Registry description
Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.

Secondary outcomes(15)

Change in Glycosylated Haemoglobin (HbA1c)
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in glycosylated haemoglobin (HbA1c) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Fasting Plasma Glucose (FPG)
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in fasting plasma glucose (FPG) from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Waist Circumference
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in waist circumference from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Systolic Blood Pressure
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in systolic blood pressure from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in triglycerides (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in total cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in very low density lipoprotein (VLDL) cholesterol (measured in mmol/L) from randomisation (week 0) to end of treatment (week 52) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Body Weight (Kilogram [Kg])
Time frame · From randomisation (week 0) to week 52
Registry description
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)
Time frame · At week 52
Registry description
Participants who achieved body weight reduction greater than or equal to 5% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)
Time frame · At week 52
Registry description
Participants who achieved body weight reduction greater than or equal to 10% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)
Time frame · At week 52
Registry description
Participants who achieved body weight reduction greater than or equal to 15% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)
Time frame · At week 52
Registry description
Participants who achieved body weight reduction greater than or equal to 20% (Yes/No) at week 52 is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Change in Pulse
Time frame · From randomisation (week 0) to end of treatment (week 52)
Registry description
Change in pulse from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.

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· From randomisation (week 0) to end of treatment (week 52)

Change in Body Weight (Percentage [%])

Group	Value (Percentage (%) of body weight)	Spread
Semaglutide 2.4 mg	-14.4	7.9
Placebo	-2.7	4.3

Primary outcomeCount of participants· At week 52

Participants With Change to Normoglycemia

Group	Value (Participants)
Semaglutide 2.4 mg	103
Placebo	9

Secondary and other outcome results(6)

Secondary outcomeMean· From randomisation (week 0) to end of treatment (week 52)

Change in Glycosylated Haemoglobin (HbA1c)

Group	Value (Percentage of HbA1c)	Spread
Semaglutide 2.4 mg	-0.4	0.3
Placebo	0.1	0.2

Secondary outcomeMean· From randomisation (week 0) to end of treatment (week 52)

Change in Fasting Plasma Glucose (FPG)

Group	Value (millimoles per liter (mmol/L))	Spread
Semaglutide 2.4 mg	-0.8	0.6
Placebo	-0.3	0.7

Secondary outcomeMean· From randomisation (week 0) to end of treatment (week 52)

Change in Waist Circumference

Group	Value (centimeter (cm))	Spread
Semaglutide 2.4 mg	-11.6	8.7
Placebo	-2.8	5.4

Secondary outcomeMean· From randomisation (week 0) to end of treatment (week 52)

Change in Systolic Blood Pressure

Group	Value (millimeters of mercury (mmHg))	Spread
Semaglutide 2.4 mg	-9	13
Placebo	-1	13

Secondary outcomeGeometric mean· From randomisation (week 0) to end of treatment (week 52)

Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

Group	Value (Ratio of triglycerides)	Spread
Semaglutide 2.4 mg	0.80	36.4
Placebo	0.96	30.6

Secondary outcomeGeometric mean· From randomisation (week 0) to end of treatment (week 52)

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

Group	Value (Ratio of total cholesterol)	Spread
Semaglutide 2.4 mg	0.94	16.1
Placebo	1.01	15.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Semaglutide 2.4 mgParticipants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	2 / 138	12 / 138	93 / 138
PlaceboParticipants received once-weekly subcutaneous (s.c) injection of 0.25 milligram (mg) placebo matched to 2.4 mg Semaglutide administered using a DV3396 pen-injector followed by a fixed-dose escalation regimen, with dose increase every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week) until the maintenance dose of 2.4 mg after 16 weeks. Treatment was continued on the maintenance dose of 2.4 mg placebo matched to 2.4 mg Semaglutide once weekly for an additional 36 weeks until week 52. The treatment was an adjunct to a reduced-calorie diet and increased physical activity.	0 / 69	6 / 69	30 / 69

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 · 2024

5 results

Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial.

McGowan et al. 2024The lancet. Diabetes & endocrinologycited by 136

PMID 39089293DOI 10.1016/s2213-8587(24)00182-7PUB-39089293

Full text at the publisher5 results

Publisher page See results (5)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female aged greater than or equal to 18 years at the time of signing informed consent. * BMI greater than or equal to 30.0 kg/m\^2 * Prediabetes defined as at least one of the following: * HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening. * FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening. Exclusion Criteria: * History of type 1 or type 2 diabetes. * Treatment with glucose-lowering agent(s) within 90 days before screening. * HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening. * FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by 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. * Treatment with any medication for the indication of obesity within the past 90 days before screening.

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