Trial Outcomes & Findings for A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes (NCT NCT05478252)

Last Updated: 2025-12-12

Results Overview

Change in HbA1c from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

388 participants

Primary outcome timeframe

From baseline (week 0) to end of treatment (week 28)

Results posted on

2025-12-12

Participant Flow

The trial was conducted at 73 sites in Slovakia, Poland, South Africa, the United States and Canada.

Participant milestones

Participant milestones
Measure	Semaglutide J Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Overall Study STARTED	291	97
Overall Study Full Analysis Set	291	97
Overall Study Safety Analysis Set	291	97
Overall Study COMPLETED	283	91
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Semaglutide J Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Overall Study Withdrawal by Subject	2	3
Overall Study Lost to Follow-up	4	2
Overall Study Physician Decision	1	1
Overall Study Death	1	0

Baseline Characteristics

A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Semaglutide J n=291 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=97 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Total n=388 Participants Total of all reporting groups
Age, Continuous	53.7 Years STANDARD_DEVIATION 7.7 • n=26 Participants	54.8 Years STANDARD_DEVIATION 7.1 • n=24 Participants	54.0 Years STANDARD_DEVIATION 7.6 • n=50 Participants
Sex: Female, Male Female	128 Participants n=26 Participants	47 Participants n=24 Participants	175 Participants n=50 Participants
Sex: Female, Male Male	163 Participants n=26 Participants	50 Participants n=24 Participants	213 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	56 Participants n=26 Participants	25 Participants n=24 Participants	81 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	235 Participants n=26 Participants	72 Participants n=24 Participants	307 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	27 Participants n=26 Participants	12 Participants n=24 Participants	39 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=26 Participants	1 Participants n=24 Participants	1 Participants n=50 Participants
Race (NIH/OMB) Black or African American	48 Participants n=26 Participants	12 Participants n=24 Participants	60 Participants n=50 Participants
Race (NIH/OMB) White	214 Participants n=26 Participants	72 Participants n=24 Participants	286 Participants n=50 Participants
Race (NIH/OMB) More than one race	2 Participants n=26 Participants	0 Participants n=24 Participants	2 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=26 Participants	0 Participants n=24 Participants	0 Participants n=50 Participants

PRIMARY outcome

Timeframe: From baseline (week 0) to end of treatment (week 28)

Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Semaglutide J n=285 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=91 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Change in Glycosylated Haemoglobin (HbA1c)	-1.7 Percentage of glycosylated haemoglobin Standard Deviation 1.0	-1.6 Percentage of glycosylated haemoglobin Standard Deviation 1.0

SECONDARY outcome

Timeframe: From baseline (week 0) to end of treatment (week 28)

Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Change in body weight from baseline (week 0) to end of treatment (week 28) is presented. The endpoint was evaluated based on the data from in-study period. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of least contact with trial site.

Outcome measures

Outcome measures
Measure	Semaglutide J n=284 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=91 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Change in Body Weight	-5.0 Kilogram (kg) Standard Deviation 5.0	-4.6 Kilogram (kg) Standard Deviation 4.4

SECONDARY outcome

Timeframe: From the time of first dosing (week 0) to end of study (week 33)

Population: Safety analysis set included all participants who are exposed to study intervention.

An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an IMP. All presented adverse events are TEAE. A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.

Outcome measures

Outcome measures
Measure	Semaglutide J n=291 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=97 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Number of Treatment-Emergent Adverse Events (TEAEs)	156 Events	52 Events

SECONDARY outcome

Timeframe: From baseline (week 0) to end of study (week 33)

Population: Safety analysis set included all participants who are exposed to study intervention. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Occurrence of anti-semaglutide antibodies for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies, whereas 'No' infers who tested negative for anti semaglutide antibodies.

Outcome measures

Outcome measures
Measure	Semaglutide J n=282 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=90 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Occurrence of Anti-semaglutide Antibodies (Yes/no) Yes	1 Participants	0 Participants
Occurrence of Anti-semaglutide Antibodies (Yes/no) No	281 Participants	90 Participants

SECONDARY outcome

Timeframe: From baseline (week 0) to end of study (week 33)

Population: Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point.

Occurrence of anti-semaglutide antibodies with in-vitro neutralizing effect was to be performed based on positive cross -reactivity to GLP-1. Since there was no sample with positive cross -reactivity to GLP-1, no further analysis was performed for invitro neutralizing effect towards native-GLP1. Therefore, no data is available for this end point. In the reported data 'yes' infers who tested positive for anti-semaglutide antibodies whereas 'No' infers who tested negative for anti-semaglutide antibodies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (week 0) to end of study (week 33)

Occurrence of anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) for in-study observation period is presented. The in-study period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. In the reported data 'yes' infers who tested positive for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1) whereas 'No' infers who tested negative for anti-semaglutide binding antibodies cross-reacting with endogenous glucagon like peptide-1 (GLP-1).

Outcome measures

Outcome measures
Measure	Semaglutide J n=1 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no) Yes	0 Participants	0 Participants
Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no) No	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At week 33

Occurrence of in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 at week 33 is presented. In the reported data 'yes' infers who tested positive for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1 whereas 'No' infers who tested negative for in-vitro neutralising cross-reacting antibodies to endogenous GLP-1.

Outcome measures

Outcome measures
Measure	Semaglutide J n=1 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no) Yes	0 Participants	0 Participants
Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no) No	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At week 33

Anti-semaglutide antibodies level measured as %Bound/Total at week 33 is presented.

Outcome measures

Outcome measures
Measure	Semaglutide J n=1 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total	3.47 Percentage of Antisemaglutide Antibodies Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: At week 33

Anti-semaglutide antibodies level measured as titre at week 33 is presented.

Outcome measures

Outcome measures
Measure	Semaglutide J n=1 Participants Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Anti-semaglutide Antibodies Level (Measured as Titre)	15.00 Titre Standard Deviation 0.00	—

Adverse Events

Semaglutide J

Serious events: 8 serious events

Other events: 64 other events

Deaths: 1 deaths

Semaglutide B

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Semaglutide J n=291 participants at risk Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=97 participants at risk Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Gastrointestinal disorders Diarrhoea	8.9% 26/291 • Number of events 32 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	7.2% 7/97 • Number of events 8 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Nervous system disorders Headache	5.8% 17/291 • Number of events 19 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	2.1% 2/97 • Number of events 2 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Gastrointestinal disorders Nausea	12.0% 35/291 • Number of events 58 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	15.5% 15/97 • Number of events 18 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Gastrointestinal disorders Vomiting	5.2% 15/291 • Number of events 16 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	5.2% 5/97 • Number of events 5 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

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

Measure	Semaglutide J n=291 participants at risk Participants initially received 0.25 mg subcutaneous injections of semaglutide J once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.	Semaglutide B n=97 participants at risk Participants initially received 0.25 mg subcutaneous injections of semaglutide B once weekly and the dose was then escalated (0.25 mg in week 0 to week 4 and 0.5 mg in week 4 to week 8) once in 4 weeks until the target maintenance dose of 1.0 mg was reached which was maintained for a period of 20 weeks. Total treatment period was 28 weeks.
Cardiac disorders Acute myocardial infarction	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Cardiac disorders Atrial fibrillation	0.00% 0/291 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	1.0% 1/97 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Cardiac disorders Cardiac failure acute	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Cardiac disorders Cardiopulmonary failure	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Renal and urinary disorders Haematuria	0.00% 0/291 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	1.0% 1/97 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Eye disorders Iridocyclitis	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Cardiac disorders Myocardial infarction	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/291 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	1.0% 1/97 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Gastrointestinal disorders Pancreatitis	0.00% 0/291 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	1.0% 1/97 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Infections and infestations Pneumonia	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/291 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	1.0% 1/97 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.
Gastrointestinal disorders Vomiting	0.34% 1/291 • Number of events 1 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.	0.00% 0/97 • From the time of first dosing (week 0) to end of study (week 33) All presented AEs are treatment-emergent (i.e., TEAEs). A TEAE is defined as an adverse event with an onset date (or increase in severity) during the on-treatment observation period. On-treatment observation period is defined as from first drug date until the end of study.