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 who have reached target dose during run-in period

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003473-34-SE

Enrollment

900

Registered

2018-02-19

Start date

2018-05-03

Completion date

Unknown

Last updated

2020-06-15

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 Other descriptive name: SEMAGLUTIDE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female, age = 18 years at the time of signing informed consent 2. BMI = 30 kg/sqm or = 27 kg/sqm with the presence of at least one of the following weightrelated 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 720 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180

Exclusion criteria

Exclusion criteria: 1. HbA1c = 48 mmol/mol (6.5%) as measured by 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 reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, 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 reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, on - cardiovascular risk factors - clinical outcome assessments 2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period.;Primary end point(s): Change in body weight (%);Timepoint(s) of evaluation of this end point: From randomisation (week 20) to week 68	—

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 reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, 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 reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period, on - cardiovascular risk factors - clinical outcome assessments 2. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of semaglutide during the run-in period.;Primary end point(s): Change in body weight (%);Timepoint(s) of evaluation of this end point: From randomisation (week 20) to week 68

—

Secondary

Measure	Time frame
Secondary end point(s): Change in: - Waist circumference (cm) - Systolic blood pressure (mmHg) - Physical functioning score (SF-36) - Total score (Weight Related Sign and Symptom Measure (WRSSM));Timepoint(s) of evaluation of this end point: From randomisation (week 20) to week 68	—

Countries

Denmark, European Union, Israel, Netherlands, Portugal, South Africa, Spain, Sweden, Switzerland, Ukraine, 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