Primary 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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Obesitas en overgewicht met co-morbiditeiten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from randomisation (week 20) to week 68 in body weight (%)
Secondary outcome
From randomisation (week 20) to week 68 change in waist circumference (cm),
systolic blood pressure (mmHg), physical functioning score (SF-36) and total
score (Weight Related Sign and Symptom Measure (WRSSM)).
Background summary
Semaglutide is the next generation glucagon-like peptide-1 (GLP-1) receptor
agonist (RA) currently under clinical development by Novo Nordisk for weight
management (NN9536). Semaglutide has been improved resulting in a longer
half-life of approximately 160 hours, making it suitable for once-weekly
dosing. GLP-1 RA is a physiological regulator of appetite and GLP-1 receptors
are present in several areas of the brain involved in appetite regulation.
The trial population will consist of subjects with obesity (BMI >= 30 kg/m2) or
with overweight (BMI >= 27 kg/m2) and weight-related comorbidities. These
subjects represent a clinically relevant population for pharmacological weight
management as they are at significant risk for weight-related morbidity and
mortality, and are likely to benefit from weight loss.
Study objective
Primary 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 objectives:
-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.
-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.
Study design
This is a 68-week, randomised, double-blind, placebo-controlled, two-armed
multi-centre, multinational withdrawal clinical trial comparing once-weekly
semaglutide s.c. 2.4 mg with semaglutide placebo in subjects with overweight or
obesity. The total trial duration for the individual subject will be
approximately 76 weeks. The trial includes a screening period of approximately
1 week. Eligible subjects will at V2 (week 0) start dose
escalation with semaglutide as an adjunct to a reduced-calorie diet and
increased physical activity for 20 weeks (run-in period). Subjects fulfilling
all randomisation criteria at V12 (week 20) will be randomised in a 2:1 manner
to either continue receiving semaglutide s.c. 2.4 mg once-weekly for
additional 48 weeks or being switched to once-weekly semaglutide placebo for 48
weeks, still as an adjunct to a reduced-calorie diet and increased physical
activity. The treatment continues until the *end of treatment* visit followed
by a 7 weeks follow-up period.
Intervention
Once-weekly semaglutide/placebo subcutaneous injection, dose 2.4 mg.
Study burden and risks
Necessary precautions have been implemented in the design and planned conduct
of the trial in order to minimise the risks and inconveniences of participation
in the trial. The safety profile for semaglutide generated from the clinical
and non-clinical development programme has not revealed
any safety issues that would prohibit administration of semaglutide s.c. 2.4 mg
once-weekly. The results of the phase 2 trial (NN9536-4153) indicated that
semaglutide provided a clinically meaningful weight loss and was generally
well-tolerated. In conclusion, the potential risk to the subjects in this trial
is considered low and outweighed by the anticipated benefits that semaglutide
would provide subjects included in the trial.
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Flemingweg 18
Alphen a/d Rijn 2408 AV
NL
Listed location countries
Age
Inclusion criteria
-Informed consent obtained before any trial-related activities
-Male or female, age >= 18 years at the time of signing informed consent
-BMI >= 30 kg/m2 or >= 27 kg/m2 with the presence of at least one of the following weightrelated
comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive
sleep apnoea or cardiovascular disease
-History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
- HbA1c >= 48 mmol/mol (6.5%) as measured by central laboratory at screening
- A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening
irrespective of medical records
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003473-34-NL |
| CCMO | NL64605.018.18 |