Trial Outcomes & Findings for A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease (NCT NCT05891496)
NCT ID: NCT05891496
Last Updated: 2026-02-24
Results Overview
Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
23 participants
Primary outcome timeframe
Baseline (week 0), week 12
Results posted on
2026-02-24
Participant Flow
The trial was conducted at 7 sites in 5 countries (Canada, Denmark, Sweden, Switzerland and the United States).
Participants with mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer's type were randomised in 1:1 ratio to receive subcutaneous (s.c.) injection of once weekly semaglutide or placebo matched to semaglutide. The final data for outcome measures 1,2 and 3 are reported with no further updates. Adverse events are presented for period 1 + period 2.
Participant milestones
| Measure |
Semaglutide
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
Placebo to Semaglutide
Participants who initially received placebo was administered with semaglutide every 4 weeks in a dose escalation manner.
|
|---|---|---|---|
|
Period 1: 12 Weeks
STARTED
|
11
|
12
|
0
|
|
Period 1: 12 Weeks
Full Analysis Set
|
11
|
12
|
0
|
|
Period 1: 12 Weeks
Safety Analysis Set
|
11
|
12
|
0
|
|
Period 1: 12 Weeks
COMPLETED
|
11
|
12
|
0
|
|
Period 1: 12 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2: 52 Weeks
STARTED
|
11
|
0
|
12
|
|
Period 2: 52 Weeks
Treated
|
10
|
0
|
12
|
|
Period 2: 52 Weeks
COMPLETED
|
0
|
0
|
0
|
|
Period 2: 52 Weeks
NOT COMPLETED
|
11
|
0
|
12
|
Reasons for withdrawal
| Measure |
Semaglutide
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
Placebo to Semaglutide
Participants who initially received placebo was administered with semaglutide every 4 weeks in a dose escalation manner.
|
|---|---|---|---|
|
Period 2: 52 Weeks
Ongoing
|
10
|
0
|
12
|
|
Period 2: 52 Weeks
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Semaglutide
n=11 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
n=12 Participants
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 Years
STANDARD_DEVIATION 5.4 • n=58 Participants
|
69.3 Years
STANDARD_DEVIATION 4.1
|
67.6 Years
STANDARD_DEVIATION 5.1 • n=1 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=58 Participants
|
8 Participants
|
15 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=58 Participants
|
4 Participants
|
8 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=58 Participants
|
12 Participants
|
23 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=58 Participants
|
12 Participants
|
23 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0), week 12Population: Full analysis set (FAS) comprised all randomised participants. Here, Overall 'Number of Participants Analysed' refers to the number of participants with available data for this outcome measure.
Change in gene expression assessed by scRNAseq (cells in CSF) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes (DEG).
Outcome measures
| Measure |
Semaglutide
n=4 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
n=7 Participants
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
|---|---|---|
|
Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF])
|
41.25 Differentially expressed genes
Standard Deviation 29.68
|
21.00 Differentially expressed genes
Standard Deviation 25.70
|
PRIMARY outcome
Timeframe: Baseline (week 0), week 12Population: FAS comprised all randomised participants. Here, Overall 'Number of Participants Analysed' refers to the number of participants with available data for this outcome measure.
Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to week 12 is presented. Change in gene expression is presented as the mean number of differentially expressed genes.
Outcome measures
| Measure |
Semaglutide
n=7 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
n=6 Participants
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
|---|---|---|
|
Change in Gene Expression Assessed by scRNAseq (Cells in Blood)
|
10.00 Differentially expressed genes
Standard Deviation 5.97
|
16.50 Differentially expressed genes
Standard Deviation 15.86
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 12Population: Safety analysis set (SAS) included all participants exposed to study intervention.
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment period.
Outcome measures
| Measure |
Semaglutide
n=11 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
n=12 Participants
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs)
|
31 Events
|
8 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) to week 64Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From week 4 to week 64Outcome measures
Outcome data not reported
Adverse Events
Semaglutide Period 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Semaglutide Period 2
Serious events: 1 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Semaglutide Period 1
n=11 participants at risk
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
n=12 participants at risk
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
Semaglutide Period 2
n=22 participants at risk
Participants from semaglutide period 1 arm received once weekly s.c. injection of maintenance dose semaglutide and participants from placebo arm received s.c. administration of semaglutide in dose escalation manner until the maintenance dose was reached up to 64 weeks.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
4.5%
1/22 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
Other adverse events
| Measure |
Semaglutide Period 1
n=11 participants at risk
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide for 12 weeks as an add on therapy to standard of care. Participants initially received once weekly semaglutide and the dose was then escalated once in 4 weeks until the maintenance dose was reached.
|
Placebo
n=12 participants at risk
Participants received once-weekly s.c. injections of placebo matched to semaglutide for 12 weeks.
|
Semaglutide Period 2
n=22 participants at risk
Participants from semaglutide period 1 arm received once weekly s.c. injection of maintenance dose semaglutide and participants from placebo arm received s.c. administration of semaglutide in dose escalation manner until the maintenance dose was reached up to 64 weeks.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.4%
4/11 • Number of events 4 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
22.7%
5/22 • Number of events 5 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
18.2%
2/11 • Number of events 3 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
4.5%
1/22 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Investigations
Weight decreased
|
45.5%
5/11 • Number of events 5 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
27.3%
6/22 • Number of events 6 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
9.1%
2/22 • Number of events 2 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
4.5%
1/22 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
4.5%
1/22 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.2%
2/11 • Number of events 2 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
General disorders
Fatigue
|
18.2%
2/11 • Number of events 2 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
4.5%
1/22 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
9.1%
2/22 • Number of events 2 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Infections and infestations
Nasopharyngitis
|
18.2%
2/11 • Number of events 2 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/12 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
9.1%
2/22 • Number of events 3 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 6 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
31.8%
7/22 • Number of events 8 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
0.00%
0/22 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
8.3%
1/12 • Number of events 1 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
9.1%
2/22 • Number of events 2 • From baseline (week 0) to end of study (week 69)
All presented adverse events (AEs) are treatment emergent adverse events (TEAEs), defined as an event with onset during the on-treatment period. Results are based on the SAS which included all participants exposed to study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER