Trial Outcomes & Findings for A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001) (NCT NCT04944992)

Last Updated: 2023-11-15

Results Overview

LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

Baseline and up to ~24 Weeks

Results posted on

2023-11-15

Participant Flow

This study was conducted at 51 clinical sites in 16 countries.

Participant flow as per the database cutoff date of 19OCT2022.

Participant milestones

Participant milestones
Measure	Efinopegdutide Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Overall Study STARTED	72	73
Overall Study COMPLETED	64	71
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Efinopegdutide Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.	Total n=145 Participants Total of all reporting groups
Age, Continuous	48.0 Years STANDARD_DEVIATION 11.0 • n=5 Participants	50.7 Years STANDARD_DEVIATION 10.9 • n=7 Participants	49.4 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	63 Participants n=7 Participants	125 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index (BMI)	35.2 Kg/M^2 STANDARD_DEVIATION 5.7 • n=5 Participants	33.5 Kg/M^2 STANDARD_DEVIATION 5.0 • n=7 Participants	34.3 Kg/M^2 STANDARD_DEVIATION 5.4 • n=5 Participants
Weight	100.2 kg STANDARD_DEVIATION 18.9 • n=5 Participants	94.4 kg STANDARD_DEVIATION 18.9 • n=7 Participants	97.3 kg STANDARD_DEVIATION 19.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and up to ~24 Weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks	72.7 Percent Reduction Interval 66.8 to 78.7	42.3 Percent Reduction Interval 36.5 to 48.1

PRIMARY outcome

Timeframe: Up to ~29 weeks

Population: All randomized participants who received at least 1 injection (including only partial) of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an adverse event is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Percentage of Participants Who Experienced an Adverse Event (AE)	88.9 Percentage of Participants	72.6 Percentage of Participants

PRIMARY outcome

Timeframe: Up to ~24 weeks

Population: All randomized participants who received at least 1 injection (including only partial) of study intervention.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Percentage of Participants Who Discontinued Study Intervention Due to an AE	5.6 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and up to ~24 Weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The absolute reduction from baseline to Week 24 = Baseline - Week 24. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks	14.9 Percentage of liver fat Interval 13.6 to 16.3	8.8 Percentage of liver fat Interval 7.5 to 10.1

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Body weight in kilograms was measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in Body Weight After 24 Weeks	-8.5 Percent Change Interval -9.5 to -7.5	-7.1 Percent Change Interval -8.1 to -6.2

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in total cholesterol. The mean percent change in total cholesterol is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks	-15.2 Percent Change Interval -18.2 to -12.2	-8.0 Percent Change Interval -11.0 to -5.0

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in non-HDL-C. The mean percent change in non-HDL-C is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks	-16.8 Percent Change Interval -20.5 to -13.0	-11.0 Percent Change Interval -14.8 to -7.3

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in HDL-C. Mean percent change in HDL-C is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks	-8.1 Percent Change Interval -11.2 to -5.1	3.6 Percent Change Interval 0.6 to 6.6

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in LDL-C. The mean percent change in LDL-C is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks	-13.0 Percent Change Interval -17.4 to -8.6	-6.9 Percent Change Interval -11.3 to -2.6

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in triglycerides. The mean percent change in triglycerides is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks	-30.9 Percent Change Interval -35.6 to -25.8	-23.3 Percent Change Interval -28.5 to -17.7

SECONDARY outcome

Timeframe: Baseline and up to ~24 weeks

Population: All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.

Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in apoB. The mean percent change in apoB is presented.

Outcome measures

Outcome measures
Measure	Efinopegdutide n=72 Participants Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 Participants Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks	-14.7 Percent Change Interval -18.2 to -11.1	-9.2 Percent Change Interval -12.8 to -5.7

Adverse Events

Efinopegdutide

Serious events: 1 serious events

Other events: 57 other events

Deaths: 0 deaths

Semaglutide

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Efinopegdutide n=72 participants at risk Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 participants at risk Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/72 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	1.4% 1/73 • Number of events 1 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Renal and urinary disorders Calculus urinary	1.4% 1/72 • Number of events 1 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	0.00% 0/73 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with ICMJE authorship requirements.
Publication restrictions are in place

Restriction type: OTHER

Measure	Efinopegdutide n=72 participants at risk Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.	Semaglutide n=73 participants at risk Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.
Gastrointestinal disorders Abdominal distension	5.6% 4/72 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	4.1% 3/73 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Abdominal pain	12.5% 9/72 • Number of events 15 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	2.7% 2/73 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Abdominal pain upper	9.7% 7/72 • Number of events 10 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	1.4% 1/73 • Number of events 1 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Constipation	16.7% 12/72 • Number of events 16 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	5.5% 4/73 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Diarrhoea	16.7% 12/72 • Number of events 32 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	17.8% 13/73 • Number of events 29 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Dyspepsia	8.3% 6/72 • Number of events 6 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	6.8% 5/73 • Number of events 5 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Flatulence	5.6% 4/72 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	1.4% 1/73 • Number of events 1 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Gastrooesophageal reflux disease	8.3% 6/72 • Number of events 6 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	6.8% 5/73 • Number of events 6 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Nausea	27.8% 20/72 • Number of events 38 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	31.5% 23/73 • Number of events 36 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Gastrointestinal disorders Vomiting	16.7% 12/72 • Number of events 23 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	15.1% 11/73 • Number of events 12 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
General disorders Fatigue	1.4% 1/72 • Number of events 1 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	8.2% 6/73 • Number of events 6 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Infections and infestations COVID-19	11.1% 8/72 • Number of events 8 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	13.7% 10/73 • Number of events 10 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Infections and infestations Urinary tract infection	5.6% 4/72 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	2.7% 2/73 • Number of events 2 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Investigations Alanine aminotransferase increased	5.6% 4/72 • Number of events 4 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	0.00% 0/73 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Investigations Lipase increased	5.6% 4/72 • Number of events 5 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	4.1% 3/73 • Number of events 3 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Metabolism and nutrition disorders Decreased appetite	16.7% 12/72 • Number of events 12 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	15.1% 11/73 • Number of events 13 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Nervous system disorders Dizziness	5.6% 4/72 • Number of events 7 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	2.7% 2/73 • Number of events 2 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.
Nervous system disorders Headache	6.9% 5/72 • Number of events 5 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.	6.8% 5/73 • Number of events 8 • Death and adverse events up to ~29 weeks Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.