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A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) (STEP UP)

Primary Purpose

Obesity

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

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

Inclusion Criteria: Male or female. Age above or equal to 18 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to 30.0 kilogram per square meter (kg/m^2). History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: HbA1c greater than or equal to 48 millimoles per mole (mmol/mol) (6.5 percent) as measured by the central laboratory at screening. History of type 1 or type 2 diabetes. Treatment with glucose-lowering agent(s) within 90 days before screening. A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening irrespective of medical records. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide 7.2 mg

Semaglutide 2.4 mg

Placebo

Arm Description

Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.

Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.

Outcomes

Primary Outcome Measures

Semaglutide 7.2 mg versus Placebo: Relative change in body weight

Measured in percentage (%).

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)

Measured as count of participants.

Secondary Outcome Measures

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=25% (yes/no)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Change in waist circumference

Measured in centimeters (cm).

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight

Measured in percentage (%).

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=20% (yes/no)

Measured as count of participants.

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Change in body weight

Measured in kilograms (kg).

Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)

Measured in kilogram per square meter (kg/m^2).

Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%)

Measured in percentage (%).

Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)

Measured in liters.

Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%)

Measured in percentage (%).

Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)

Measured in liters.

Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%)

Measured in percentage (%).

Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)

Measured in liters.

Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure

Measured in millimeters of mercury (mmHg).

Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure

Measured in mmHg.

Semaglutide 7.2 mg versus Placebo: Change in total cholesterol

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Change in very low-density lipoprotein (VLDL) cholesterol

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Change in triglycerides

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Change in free fatty acids

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Number of participants with change in antihypertensive treatment (decrease, no change, increase)

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)

Measured in percentage (%).

Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose

Measured in milligrams per deciliter (mg/dL).

Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin

Measured in ratio to baseline.

Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])

Measured as count of participants.

Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)

Measured as count of events.

Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)

Measured as count of events.

Semaglutide 7.2 mg versus Placebo: Change in pulse

Measured in beats per minute (bmp).

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs

Measured as count of events.

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs

Measured as count of events.

Full Information

NCT ID

NCT05646706

First Posted

December 2, 2022

Last Updated

July 10, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT05646706

Brief Title

A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

Acronym

STEP UP

Official Title

Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 4, 2023 (Actual)

Primary Completion Date

September 13, 2024 (Anticipated)

Study Completion Date

November 15, 2024 (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

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will look at how much weight participants will lose from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. In the first part of the study, participants will get one injection once a week until they reach the planned dose. The second part of the study, which might last a couple of months, is a transition period, where participant will get three injections, taken right after each other, once a week. The duration of the study intervention (trial product and lifestyle intervention) will be 72 weeks followed by a 9-week follow-up period without study interventions.

6. Conditions and Keywords

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

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1407 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide 7.2 mg

Arm Type

Experimental

Arm Description

Arm Title

Semaglutide 2.4 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals.

Primary Outcome Measure Information:

Title

Semaglutide 7.2 mg versus Placebo: Relative change in body weight

Description

Measured in percentage (%).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Secondary Outcome Measure Information:

Title

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=25% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in waist circumference

Description

Measured in centimeters (cm).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Relative change in body weight

Description

Measured in percentage (%).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=20% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of participants who achieve body weight reduction >=25% (yes/no)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in body weight

Description

Measured in kilograms (kg).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)

Description

Measured in kilogram per square meter (kg/m^2).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in total fat mass (%)

Description

Measured in percentage (%).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in total fat mass (liters)

Description

Measured in liters.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in lean body mass (%)

Description

Measured in percentage (%).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in lean body mass (liters)

Description

Measured in liters.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (%)

Description

Measured in percentage (%).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in visceral fat mass (liters)

Description

Measured in liters.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure

Description

Measured in millimeters of mercury (mmHg).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure

Description

Measured in mmHg.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in total cholesterol

Description

Measured in ratio to baseline.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol

Description

Measured in ratio to baseline.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol

Description

Measured in ratio to baseline.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: 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 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in triglycerides

Description

Measured in ratio to baseline.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in free fatty acids

Description

Measured in ratio to baseline.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: 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 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants with change in lipid-lowering treatment (decrease, no change, increase)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants with change in antihypertensive treatment (decrease, no change, increase)

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)

Description

Measured in percentage (%).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose

Description

Measured in milligrams per deciliter (mg/dL).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin

Description

Measured in ratio to baseline.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of participants with change in glycaemic category (Normo-glycaemia, pre-diabetes, type 2 diabetes [T2D])

Description

Measured as count of participants.

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)

Description

Measured as count of events.

Time Frame

From baseline (week 0) to end of study (week 81)

Title

Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)

Description

Measured as count of events.

Time Frame

From baseline (week 0) to end of study (week 81)

Title

Semaglutide 7.2 mg versus Placebo: Change in pulse

Description

Measured in beats per minute (bmp).

Time Frame

From baseline (week 0) to end of treatment (week 72)

Title

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs

Description

Measured as count of events.

Time Frame

From baseline (week 0) to end of study (week 81)

Title

Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs

Description

Measured as count of events.

Time Frame

From baseline (week 0) to end of study (week 81)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78704

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Longview

State/Province

Texas

ZIP/Postal Code

75605

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22601-3834

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kozloduy

ZIP/Postal Code

3320

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Lukovit

ZIP/Postal Code

5770

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Petrich

ZIP/Postal Code

2850

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Smolyan

ZIP/Postal Code

4700

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1202

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1618

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3Z 2N6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 5G8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8M 1K7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N5W 6A2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Benátky Na Jizerou

ZIP/Postal Code

29471

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Broumov

ZIP/Postal Code

550 01

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 10

ZIP/Postal Code

10034

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 4

ZIP/Postal Code

14021

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha 4

ZIP/Postal Code

149 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Praha

ZIP/Postal Code

160 00

Country

Czechia

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

13597

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Elsterwerda

ZIP/Postal Code

04910

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Essen

ZIP/Postal Code

45219

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48153

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Oldenburg in Holstein

ZIP/Postal Code

23758

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Rehlingen-Siersburg

ZIP/Postal Code

66780

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Wangen

ZIP/Postal Code

88239

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Witten

ZIP/Postal Code

58455

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-15125

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-17562

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Haidari-Athens

ZIP/Postal Code

GR-12462

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Lamia

ZIP/Postal Code

GR35100

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54635

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54636

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57001

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Baja

State/Province

Bács-Kiskun

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1132

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Debrecen

ZIP/Postal Code

4025

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Nyíregyháza

ZIP/Postal Code

4405

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Oslo

ZIP/Postal Code

0373

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Tønsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Lublin

State/Province

Lubelskie

ZIP/Postal Code

20-044

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

State/Province

Lubelski

ZIP/Postal Code

20-538

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Krakow

State/Province

Malopolskie

ZIP/Postal Code

31-261

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

00-710

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

State/Province

Podlaskie

ZIP/Postal Code

15-481

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Gdynia

State/Province

Pomorskie

ZIP/Postal Code

81-338

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Katowice

ZIP/Postal Code

40-752

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lisboa

ZIP/Postal Code

1250-230

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Matosinhos

ZIP/Postal Code

4464-513

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

821 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

842 31

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Lucenec

ZIP/Postal Code

984 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Malacky

ZIP/Postal Code

901 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Martin

ZIP/Postal Code

036 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Zilina

ZIP/Postal Code

01001

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1818

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1820

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

1827

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu Natal

ZIP/Postal Code

4093

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Umkomaas

State/Province

KwaZulu-Natal

ZIP/Postal Code

4170

Country

South Africa

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 Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)

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A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) (STEP UP)

Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial