This study has been transitioned to CTIS with ID 2023-506929-11-00 check the CTIS register for the current data. Primary To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus placebo as adjuncts to reduced-calorie diet…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas en overgewicht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Relative change in body weight From baseline (week 0) to end of treatment (week
68) %
Achievement of >= 5% weight reduction From baseline (week 0) to end of treatment
(week 68)
Secondary outcome
Achievement of >= 20% weight reduction From baseline (week 0) to end of
treatment (week 68)
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement
of >= 25% weight reduction.
Achievement of >= 25% weight reduction From baseline (week 0) to end of
treatment (week 68)
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement
of >= 30% weight reduction.
Achievement of >= 30% weight reduction From baseline (week 0) to end of
treatment (week 68)
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on
body weight.
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on
body weight.
Relative change in body weight From baseline (week 0) to end of treatment (week
68) %
To confirm superiority of CagriSema 0.5 mg/0.5 mg versus placebo on body weight
Relative change in body weight From baseline (week 0) to week 8 %
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on body weight
Relative change in body weight From baseline (week 0) to week 20 %
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on:
• Waist circumference
• Systolic blood pressure
• Physical functioning Change in waist circumference From baseline (week 0) to
end of treatment (week 68) cm
Change in systolic blood pressure (SBP) From baseline (week 0) to end of
treatment (week 68) mmHg
Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version
(IWQOL-Lite-CT) Physical Function score From baseline (week 0) to end of
treatment (week 68) Score points
Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score From
baseline (week 0) to end of treatment (week 68) Score points
Secondary supportive safety endpoints
To compare the safety and tolerability of CagriSema 2.4 mg/2.4 mg versus
placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg.
Number of Treatment-emergent Adverse Events (TEAEs) From baseline (week 0) to
end of studymain (week 75) Count of events
Number of Treatment-emergent Serious adverse events (TESAEs) From baseline
(week 0) to end of studymain (week 75) Count of events
Background summary
The prevalence of obesity has been increasing during the last 30 years and
globally, more than
650 million people have obesity. Obesity is associated with an increased risk
of developing type 2
diabetes (T2D), dyslipidaemia, hypertension, cardiovascular (CV) disease,
obstructive sleep
apnoea, Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis
(NAFLD/NASH),
urinary incontinence, several types of cancers, and increased mortality. In
addition,
individuals with obesity experience reduced health-related quality of life
including reduced physical
function. Several associations, organisations and individual countries have
recognized that
obesity should be treated as a chronic disease.
Semaglutide is a Glucagon-Like Peptide-1 (GLP-1). GLP-1 is an incretin hormone
released from intestinal L-cells with a glucose-dependent stimulatory effect on
insulin and inhibitory effect on glucagon secretion from the pancreatic islets.
In addition, supraphysiological levels of GLP-1 induce reduction in body weight.
Cagrilintide is an amylin analogue. Endogenous amylin is a neuroendocrine
peptide hormone that is co-secreted with insulin by pancreatic beta-cells in
response to food intake. It affects a number of GI processes including delay of
gastric emptying and suppression of post-prandial glucagon release.
Cagrilintide in combination with semaglutide is currently under development by
Novo Nordisk for the weight management indication. Combining anti-obesity
medications with different modes of action may offer superior
weight loss when compared to the monocomponents.
Study objective
This study has been transitioned to CTIS with ID 2023-506929-11-00 check the CTIS register for the current data.
Primary
To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg
versus placebo as adjuncts to reduced-calorie diet and
increased physical activity in participants with overweight or obesity.
Secondary
To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement
of >= 20% weight reduction.
Study design
The study consists of a main phase and an extension phase.
The total duration of the main phase for each participant will be approximately
78 weeks (up to 3 weeks screening, 68 weeks treatment and 7 weeks follow-up).
The 68-week main phase of the present study is designed to compare the efficacy
and safety of once-weekly cagrilintide s.c. in combination with semaglutide
s.c. (CagriSema s.c.) versus once-weekly cagrilintide s.c., semaglutide s.c.
and s.c placebo, all as an adjunct to a reduced-calorie diet and increased
physical activity, for weight management in participants with overweight or
obesity.
After the main phase there will be a waiting period for all randomised
participants until DBL and unblinding of sponsor has occurred. After the
waiting period the participants will be informed if they are in the extension
phase or not. Only participants randomised to either CagriSema or placebo are
part of the extension phase. During the extension phase, participants will not
receive study intervention (i.e. neither intervention with diet and physical
activity counselling nor investigational medicinal product (IMP)) and will thus
be considered off-treatment.
The duration of the extension phase, including the waiting period, is 97 weeks.
Intervention
Subjects are randomised (21:3:3:7) in the groups: subcutaneous injection of
cagrisema (cagrilintide/semaglutide) 2.4 mg/2.4 mg, cagrilintide 2.4 mg,
semaglutide 2.4 mg or placebo once weekly.
All participants will receive counselling on diet and physical activity,
provided by a dietitian or similar qualified health professional, every 4th
week at the remote/site visits during the treatment period and at end of
studymain visit (V26).
Study burden and risks
Participants will be treated with a regimen anticipated to be better than or
equal to the weight management they receive at the time of entry into the study.
In the semaglutide weight management programme, the 68-week STEP 1 study
(NN9536-4373), which included a similar study population as this study,
demonstrated clinically significant weight loss with semaglutide s.c. 2.4 mg
once-weekly.
Semaglutide s.c. 2.4 mg once-weekly had a safe and well-tolerated profile,
consistent with previous findings for semaglutide and GLP-1 RAs.
A 26-week phase 2 clinical study (NN9838-4433) investigating cagrilintide
once-weekly has been completed in participants with overweight or obesity. A
dose dependent decrease in body weight with increasing doses of cagrilintide
was demonstrated. A higher proportion of participants achieved a body weight
loss of at least 5% and 10% at week 26 with increasing doses of cagrilintide
compared to participants that received placebo.
A 20-week treatment phase 1 clinical study (NN9838-4395) investigating
ascending once-weekly doses of cagrilintide in combination with semaglutide has
been completed in participants with overweight or obesity. A substantial weight
loss was observed in participants receiving cagrilintide 1.2, 2.4, and 4.5 mg
in combination with semaglutide 2.4 mg when compared to placebo with
semaglutide 2.4 mg.
In addition, it is expected that all participants will benefit from
participation through close contact with the site staff and diet and physical
activity counselling by a dietician or a similar qualified healthcare
professional.
Extension phase
Participants who continue in the extension phase are expected to benefit from
the continued contact with the site staff focusing on general health, including
body weight, CV risk factors and glucose metabolism parameters.
Taking into account the measures taken to minimise risk and burden to
participants participating in this study, the potential risks identified in
association with CagriSema, cagrilintide and semaglutide are justified by the
anticipated benefits that may be afforded to participants with overweight or
obesity.
Flemingweg 8
Alphen aan den Rijn 2408AV
NL
Flemingweg 8
Alphen aan den Rijn 2408AV
NL
Listed location countries
Age
Inclusion criteria
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- BMI greater than or equal to 30.0 kg/m^2 or b) BMI greater than or equal to
27.0 kg/m^2 with the presence of at least one weight related comorbidity
including, but not limited to hypertension, dyslipidaemia, obstructive sleep
apnoea or cardiovascular disease
Exclusion criteria
Glycaemia related:
-HbA1c greater than or equal to 6.5 % (48 mmol/mol) as measured by the central
laboratory at screening
-History of type 1 or type 2 diabetes mellitus
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 |
|---|---|
| EU-CTR | CTIS2023-506929-11-00 |
| EudraCT | EUCTR2020-005435-75-NL |
| CCMO | NL80969.041.22 |