STEP 5: Two-year research study investigating how well semaglutide works in people suffering from overweight or obesity

Two-year effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003726-32-HU

Enrollment

300

Registered

2018-06-15

Start date

2018-08-22

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Overweight MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Semaglutide B 3.0 mg/mL PDS290 Pharmaceutical Form: Solution for injection INN or Proposed INN: semaglutide CAS Number: 910463-68-2 Other descriptive name: SEMAGLUTIDE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, age 18 years or older at the time of signing informed consent 2. Body mass index (BMI) equal to or above 30 kg/sqm or equal to or above 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease 3. History of at least one self-reported unsuccessful dietary effort to lose body weight Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening 2. A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the two-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight.;Secondary Objective: 1. To compare the two-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on: - Cardiovascular risk factors - Glucose metabolism 2. To compare the one-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight 3. To compare the two-year safety and tolerability of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity.;Primary end point(s): The primary endpoints addressing the primary objective: 1. Change in body weight (%) 2. Subjects who achieve (yes/no): - Body weight reduction equal to or above 5%;Timepoint(s) of evaluation of this end point: 1. + 2. From baseline (week 0) to week 104	—

Measure

Time frame

Main Objective: To compare the two-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight.;Secondary Objective: 1. To compare the two-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on: - Cardiovascular risk factors - Glucose metabolism 2. To compare the one-year effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity on body weight 3. To compare the two-year safety and tolerability of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity.;Primary end point(s): The primary endpoints addressing the primary objective: 1. Change in body weight (%) 2. Subjects who achieve (yes/no): - Body weight reduction equal to or above 5%;Timepoint(s) of evaluation of this end point: 1. + 2. From baseline (week 0) to week 104

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1. After 104 weeks 2. From baseline (week 0) to week 104;Secondary end point(s): Confirmatory secondary endpoints: 1. Subjects who achieve (yes/no): - Body weight reduction equal to or above 10% from baseline (week 0) - Body weight reduction equal to or above 15% from baseline (week 0) 2. Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1. After 104 weeks 2. From baseline (week 0) to week 104;Secondary end point(s): Confirmatory secondary endpoints: 1. Subjects who achieve (yes/no): - Body weight reduction equal to or above 10% from baseline (week 0) - Body weight reduction equal to or above 15% from baseline (week 0) 2. Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg)

—

Countries

Canada, European Union, Hungary, Italy, Spain, United States

Contacts

Public ContactClinical Disclosure (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026