Trial Outcomes & Findings for A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. (NCT NCT04019561)

NCT ID: NCT04019561

Last Updated: 2023-01-17

Results Overview

The number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) through the end of the follow-up period

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: Day 1 - Day 161
• Results posted on: 2023-01-17

Participant Flow

Participant milestones

Measure	MEDI0382 300 ug MEDI0382 300 ug	MEDI0382 600 ug MEDI0382 600 ug	Placebo Placebo
Overall Study STARTED	25	25	24
Overall Study COMPLETED	21	23	19
Overall Study NOT COMPLETED	4	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.

Baseline characteristics by cohort

Measure	MEDI0382 300 ug n=25 Participants MEDI0382 300 ug	MEDI0382 600 ug n=25 Participants MEDI0382 600 ug	Placebo n=24 Participants Placebo	Total n=74 Participants Total of all reporting groups
Age, Continuous	55.9 Years STANDARD_DEVIATION 10.5 • n=5 Participants	59.4 Years STANDARD_DEVIATION 11.9 • n=7 Participants	52.2 Years STANDARD_DEVIATION 13.5 • n=5 Participants	55.9 Years STANDARD_DEVIATION 12.2 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized ASIAN	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized WHITE	24 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	71 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 - Day 161

The number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE) through the end of the follow-up period

Outcome measures

Measure	MEDI0382 300ug n=26 Participants MEDI0382 300ug	MEDI0382 600ug n=24 Participants MEDI0382 600ug	Placebo n=24 Participants Placebo
Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE Participants with any AE	20 Participants	22 Participants	9 Participants
Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE Participants with any AE with outcome of death	0 Participants	0 Participants	0 Participants
Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE Participants with any SAE (including events with outcome of death)	1 Participants	1 Participants	1 Participants
Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE Participants with any AE leading to discontinuation of investigational product	2 Participants	4 Participants	1 Participants
Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE Participants with any AE leading to withdrawal from study	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 - Day 161 (Baseline, Week 6, Week 12, Week 16, Week 19 and Week 23)

Population: Number Analyzed per Row reflects the participants with positive ADA results at each time point. With zero positive ADA results Number Analyzed is zero for Participants.

Development of ADA titer (if confirmed positive)

Outcome measures

Measure	MEDI0382 300ug n=26 Participants MEDI0382 300ug	MEDI0382 600ug n=24 Participants MEDI0382 600ug	Placebo n=24 Participants Placebo
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive) Baseline	15 ADA titer Interval 15.0 to 15.0	—	—
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive) Week 6	120 ADA titer Interval 120.0 to 120.0	60 ADA titer Interval 60.0 to 60.0	—
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive) Week 12	30 ADA titer Interval 15.0 to 960.0	15 ADA titer Interval 15.0 to 30.0	—
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive) Week 16	60 ADA titer Interval 15.0 to 480.0	60 ADA titer Interval 15.0 to 60.0	—
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive) Week 19	120 ADA titer Interval 15.0 to 480.0	30 ADA titer Interval 15.0 to 120.0	—
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive) Week 23	120 ADA titer Interval 15.0 to 480.0	30 ADA titer Interval 15.0 to 240.0	—

SECONDARY outcome

Timeframe: Day 1 - Day 161

Population: As-treated

Development of ADA during treatment and follow-up

Outcome measures

Measure	MEDI0382 300ug n=25 Participants MEDI0382 300ug	MEDI0382 600ug n=25 Participants MEDI0382 600ug	Placebo n=24 Participants Placebo
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at Week 19	8 Participants	9 Participants	0 Participants
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at Week 23	7 Participants	9 Participants	0 Participants
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at baseline	1 Participants	0 Participants	0 Participants
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at Week 2	0 Participants	0 Participants	0 Participants
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at Week 6	2 Participants	1 Participants	0 Participants
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at Week 12	8 Participants	6 Participants	0 Participants
Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA Number of subjects with a positive result at Week 16	8 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Change from baseline is defined as the week 19 post-baseline value minus the baseline value. The Analysis of Covariance (ANCOVA) model was used to fit change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=21 Participants MEDI0382 300ug	MEDI0382 600ug n=23 Participants MEDI0382 600ug	Placebo n=22 Participants Placebo
Change From Baseline to Week 19 in Hepatic Fat Fraction (HFF)	-1.25 Percent Standard Error 1.294	-4.85 Percent Standard Error 1.236	0.16 Percent Standard Error 1.262

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=21 Participants MEDI0382 300ug	MEDI0382 600ug n=23 Participants MEDI0382 600ug	Placebo n=22 Participants Placebo
Percent Change From Baseline to Week 19 in Liver Volume	-0.886 Percent change Standard Error 2.7979	-8.669 Percent change Standard Error 2.6504	0.622 Percent change Standard Error 2.6182

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=21 Participants MEDI0382 300ug	MEDI0382 600ug n=23 Participants MEDI0382 600ug	Placebo n=22 Participants Placebo
Percent Change From Baseline to Week 19 in Liver Fat Volume	-2.466 Percent change Standard Error 10.6732	-29.121 Percent change Standard Error 10.2021	8.274 Percent change Standard Error 10.1350

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=18 Participants MEDI0382 300ug	MEDI0382 600ug n=20 Participants MEDI0382 600ug	Placebo n=21 Participants Placebo
Percent Change From Baseline to Week 19 in Visceral Adipose Tissue	3.359 Percent change Standard Error 3.3107	-2.152 Percent change Standard Error 2.8958	-2.901 Percent change Standard Error 2.9198

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=13 Participants MEDI0382 300ug	MEDI0382 600ug n=17 Participants MEDI0382 600ug	Placebo n=15 Participants Placebo
Percent Change From Baseline to Week 19 in Subcutaneous Adipose Tissue	-2.240 Percent change Standard Error 2.4326	-1.778 Percent change Standard Error 1.8751	1.042 Percent change Standard Error 1.9478

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=19 Participants MEDI0382 300ug	MEDI0382 600ug n=22 Participants MEDI0382 600ug	Placebo n=20 Participants Placebo
Percent Change From Baseline to Week 19 in Liver Diffusion	2.864 Percent change Standard Error 2.9769	2.932 Percent change Standard Error 2.7798	1.826 Percent change Standard Error 2.9634

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=15 Participants MEDI0382 300ug	MEDI0382 600ug n=18 Participants MEDI0382 600ug	Placebo n=17 Participants Placebo
Percent Change From Baseline to Week 19 in Abdominal Sagittal Diameter	2.791 Percent change Standard Error 1.4722	-1.044 Percent change Standard Error 1.2793	-0.657 Percent change Standard Error 1.2881

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=15 Participants MEDI0382 300ug	MEDI0382 600ug n=18 Participants MEDI0382 600ug	Placebo n=17 Participants Placebo
Percent Change From Baseline to Week 19 in Abdominal Transversal Diameter	0.605 Percent change Standard Error 0.8585	-0.100 Percent change Standard Error 0.7458	0.991 Percent change Standard Error 0.7443

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=24 Participants MEDI0382 300ug	MEDI0382 600ug n=24 Participants MEDI0382 600ug	Placebo n=22 Participants Placebo
Percent Change From Baseline to Week 19 in Alanine Aminotransferase (ALT)	-10.414 Percent change Standard Error 10.1837	-15.465 Percent change Standard Error 10.1654	8.863 Percent change Standard Error 10.6258

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=24 Participants MEDI0382 300ug	MEDI0382 600ug n=24 Participants MEDI0382 600ug	Placebo n=22 Participants Placebo
Percent Change From Baseline to Week 19 in Gamma Glutamyl Transferase (GGT)	-5.876 Percent change Standard Error 13.6449	11.600 Percent change Standard Error 13.6079	4.514 Percent change Standard Error 14.2134

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=24 Participants MEDI0382 300ug	MEDI0382 600ug n=24 Participants MEDI0382 600ug	Placebo n=22 Participants Placebo
Percent Change From Baseline to Week 19 in Aspartate Aminotransferase (AST)	-3.447 Percent change Standard Error 9.0121	-13.951 Percent change Standard Error 8.9326	5.693 Percent change Standard Error 9.2942

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Percent change from baseline is calculated as the week 19 post-baseline value minus the baseline value divided by the baseline value *100. The Analysis of Covariance (ANCOVA) model was used to fit percent change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=25 Participants MEDI0382 300ug	MEDI0382 600ug n=25 Participants MEDI0382 600ug	Placebo n=23 Participants Placebo
Percent Change From Baseline to Week 19 in Body Weight	-1.286 Percent change Standard Error 0.8589	-2.933 Percent change Standard Error 0.8624	-0.568 Percent change Standard Error 0.8959

SECONDARY outcome

Timeframe: Baseline to week 19

Population: The intent-to-treat (ITT) population includes all enrolled participants who are randomized. ITT population was analyzed according to the randomized treatment group. The analyses include those participants who discontinue from study treatments but are still followed up for their scheduled visits.

Change from baseline is defined as the week 19 post-baseline value minus the baseline value. The Analysis of Covariance (ANCOVA) model was used to fit change at week 19. The group of treatment was considered as a fixed effect of the model while the baseline value as covariate. Last observation carried forward (LOCF) method was applied to handle missing data.

Outcome measures

Measure	MEDI0382 300ug n=25 Participants MEDI0382 300ug	MEDI0382 600ug n=25 Participants MEDI0382 600ug	Placebo n=23 Participants Placebo
Change From Baseline to Week 19 in Body Mass Index (BMI)	-0.349 kg/m2 Standard Error 0.3200	-1.042 kg/m2 Standard Error 0.3202	-0.265 kg/m2 Standard Error 0.3338

Adverse Events

MEDI0382 300 ug

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

MEDI0382 600 ug

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	MEDI0382 300 ug n=26 participants at risk MEDI0382 300 ug	MEDI0382 600 ug n=24 participants at risk MEDI0382 600 ug	Placebo n=24 participants at risk Placebo
Infections and infestations Appendicitis	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Infections and infestations Diverticulitis	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.

Other adverse events

Measure	MEDI0382 300 ug n=26 participants at risk MEDI0382 300 ug	MEDI0382 600 ug n=24 participants at risk MEDI0382 600 ug	Placebo n=24 participants at risk Placebo
Gastrointestinal disorders Constipation	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Diarrhoea	11.5% 3/26 • Number of events 3 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	20.8% 5/24 • Number of events 5 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Dry mouth	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Dyspepsia	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Enteritis	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Eructation	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Flatulence	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Nausea	53.8% 14/26 • Number of events 28 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	83.3% 20/24 • Number of events 42 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	12.5% 3/24 • Number of events 3 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Vomiting	11.5% 3/26 • Number of events 3 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	41.7% 10/24 • Number of events 17 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Cardiac disorders Tachycardia	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Asthenia	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Chest pain	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Fatigue	3.8% 1/26 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site erythema	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site haematoma	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site haemorrhage	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site irritation	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site pain	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site reaction	11.5% 3/26 • Number of events 3 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Injection site urticaria	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Endocrine disorders Hypothyroidism	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Nodule	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
General disorders Peripheral swelling	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Infections and infestations Bronchitis	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Infections and infestations Diverticulitis	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Infections and infestations Nasopharyngitis	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Infections and infestations Tooth abscess	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Infections and infestations Urinary tract infection	7.7% 2/26 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Investigations Blood calcitonin increased	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Eye disorders Vitreous floaters	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Investigations Blood creatinine increased	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Investigations Blood urea increased	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Investigations Transaminases increased	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 3 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Metabolism and nutrition disorders Decreased appetite	23.1% 6/26 • Number of events 6 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	20.8% 5/24 • Number of events 5 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Metabolism and nutrition disorders Hyperkalaemia	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Metabolism and nutrition disorders Hypoglycaemia	7.7% 2/26 • Number of events 4 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Metabolism and nutrition disorders Metabolic acidosis	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	16.7% 4/24 • Number of events 4 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Nervous system disorders Hypoaesthesia	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Nervous system disorders Paraesthesia	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Renal and urinary disorders Dysuria	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Renal and urinary disorders Pollakiuria	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Respiratory, thoracic and mediastinal disorders Asthma	7.7% 2/26 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	8.3% 2/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 2 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Vascular disorders Haematoma	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Vascular disorders Hypertension	3.8% 1/26 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Abdominal pain	7.7% 2/26 • Number of events 3 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/26 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	0.00% 0/24 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.	4.2% 1/24 • Number of events 1 • Treatment Emergent Adverse Events and Serious Adverse Events are summarized from the first dose of IP throughout the treatment period of 19 weeks and including the follow-up period of 4 weeks - a total of 23 weeks. One participant randomized to 600ug received 300ug.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60