Research study investigating how well semaglutide works in people suffering from overweight or obesity

Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003436-36-GB

Enrollment

1950

Registered

2018-02-12

Start date

2018-05-17

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, age = 18 years at the time of signing informed consent 2. Body mass index (BMI) = 30 kg/sqm or = 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 1560 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 390

Exclusion criteria

Exclusion criteria: 1. HbA1C = 48 mmol/mol (6.5%) as measured by the central laboratory at screening 2. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the 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 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 - Clinical Outcome Assessments (COAs) 2. To compare the 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): 1. Change in body weight (%) 2. Subjects who achieve body weight reduction = 5% (yes/no) ; Timepoint(s) of evaluation of this end point: 1. From baseline at week 0 to week 68 2. After 68 weeks from baseline at week 0	—

Measure

Time frame

Main Objective: To compare the 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 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 - Clinical Outcome Assessments (COAs) 2. To compare the 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): 1. Change in body weight (%) 2. Subjects who achieve body weight reduction = 5% (yes/no) ; Timepoint(s) of evaluation of this end point: 1. From baseline at week 0 to week 68 2. After 68 weeks from baseline at week 0

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Secondary

Measure	Time frame
Secondary end point(s): 1. Subjects who achieve (yes/no): - Body weight reduction = 10% - Body weight reduction = 15% 2. Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg) - Physical functioning score (SF-36) - Physical function domain (5-items) score (IWQoL-Lite for CT) ; Timepoint(s) of evaluation of this end point: 1. After 68 weeks from baseline at week 0 2. From baseline at week 0 to week 68	—

Measure

Time frame

Secondary end point(s): 1. Subjects who achieve (yes/no): - Body weight reduction = 10% - Body weight reduction = 15% 2. Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg) - Physical functioning score (SF-36) - Physical function domain (5-items) score (IWQoL-Lite for CT) ; Timepoint(s) of evaluation of this end point: 1. After 68 weeks from baseline at week 0 2. From baseline at week 0 to week 68

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Countries

Argentina, Belgium, Bulgaria, Canada, Denmark, European Union, Finland, India, Japan, Mexico, Poland, Russian Federation, Taiwan, United Kingdom, 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