Trial Outcomes & Findings for A Study of Tirzepatide in Overweight and Very Overweight Participants (NCT NCT04311411)

NCT ID: NCT04311411

Last Updated: 2024-05-22

Results Overview

Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

114 participants

Primary outcome timeframe

Baseline, Week 3

Results posted on

2024-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall.	Tirzepatide Participants received tirzepatide 5 milligrams (mg) once weekly (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Overall Study STARTED	39	37	38
Overall Study Received at Least One Dose of Study Drug	39	37	38
Overall Study COMPLETED	34	31	36
Overall Study NOT COMPLETED	5	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo administered into the subcutaneous (SC) tissue of the abdominal wall.	Tirzepatide Participants received tirzepatide 5 milligrams (mg) once weekly (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Overall Study Adverse Event	2	3	2
Overall Study Withdrawal by Subject	3	3	0

Baseline Characteristics

A Study of Tirzepatide in Overweight and Very Overweight Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=39 Participants Participants received placebo administered into the SC tissue of the abdominal wall.	Tirzepatide n=37 Participants Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide n=38 Participants Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.	Total n=114 Participants Total of all reporting groups
Age, Continuous	46.2 years STANDARD_DEVIATION 9.5 • n=5 Participants	44.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	43.7 years STANDARD_DEVIATION 11.9 • n=5 Participants	44.9 years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	36 Participants n=7 Participants	25 Participants n=5 Participants	97 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	36 Participants n=7 Participants	35 Participants n=5 Participants	108 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	83 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	39 Participants n=5 Participants	37 Participants n=7 Participants	38 Participants n=5 Participants	114 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 3

Population: All randomized participants who received at least 1 dose of the placebo or tirzepatide and had evaluable data for this outcome measure.

Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants received placebo administered into the SC tissue of the abdominal wall.	Tirzepatide n=32 Participants Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3	10.95 kilocalories (kcal) Standard Error 49.06	-523.15 kilocalories (kcal) Standard Error 52.78	—

SECONDARY outcome

Timeframe: Baseline, Week 3

Population: All randomized participants who received at least 1 dose of the study drug and had evaluable data. Overall number of participants analyzed are the participants who were evaluable for the outcome measure and number analyzed includes participants who were evaluable for the given categories.

Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment\*Week + Participant + Random Error.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants received placebo administered into the SC tissue of the abdominal wall.	Tirzepatide n=25 Participants Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide n=31 Participants Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas Insula	-0.0739 Arbitrary Units Standard Error 0.0740	-0.0301 Arbitrary Units Standard Error 0.0771	0.0190 Arbitrary Units Standard Error 0.0738
Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas Medial frontal gyrus	0.0504 Arbitrary Units Standard Error 0.0649	0.0494 Arbitrary Units Standard Error 0.0680	0.0581 Arbitrary Units Standard Error 0.0658
Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas Superior temporal gyrus	0.0132 Arbitrary Units Standard Error 0.0838	0.0174 Arbitrary Units Standard Error 0.0881	0.0621 Arbitrary Units Standard Error 0.0839
Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas Precentral gyrus	0.0441 Arbitrary Units Standard Error 0.0580	0.0249 Arbitrary Units Standard Error 0.0616	0.0845 Arbitrary Units Standard Error 0.0593
Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas Cingulate gyrus	0.0283 Arbitrary Units Standard Error 0.0615	0.0214 Arbitrary Units Standard Error 0.0643	0.0967 Arbitrary Units Standard Error 0.0623

SECONDARY outcome

Timeframe: Baseline, Week 3

The VAS determines the effects on appetite sensations and desire for specific foods. It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 individual scores (satiety + fullness + \[100-prospective food consumption\] + \[100-hunger\]/4). The higher overall appetite score indicates less appetite, and the lower score indicates more appetite.

Outcome measures

Outcome measures
Measure	Placebo n=36 Participants Participants received placebo administered into the SC tissue of the abdominal wall.	Tirzepatide n=32 Participants Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide n=36 Participants Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score Fasting (Pre-lunch)	2.15 score on a scale Standard Error 3.02	22.72 score on a scale Standard Error 3.30	8.78 score on a scale Standard Error 3.11
Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score Postprandial (Post-lunch)	-0.59 score on a scale Standard Error 2.08	1.66 score on a scale Standard Error 2.23	0.05 score on a scale Standard Error 2.12

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Tirzepatide

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Liraglutide

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=39 participants at risk Participants received placebo administered into the SC tissue of the abdominal wall.	Tirzepatide n=37 participants at risk Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide n=38 participants at risk Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Infections and infestations COVID-19 pneumonia	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	0.00% 0/37 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	2.6% 1/38 • Number of events 1 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Placebo n=39 participants at risk Participants received placebo administered into the SC tissue of the abdominal wall.	Tirzepatide n=37 participants at risk Participants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.	Liraglutide n=38 participants at risk Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg QD for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Gastrointestinal disorders Abdominal distension	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	13.5% 5/37 • Number of events 5 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	2.6% 1/38 • Number of events 1 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Abdominal pain upper	2.6% 1/39 • Number of events 1 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	10.8% 4/37 • Number of events 4 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	2.6% 1/38 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Constipation	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	18.9% 7/37 • Number of events 10 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	13.2% 5/38 • Number of events 5 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Diarrhoea	5.1% 2/39 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	13.5% 5/37 • Number of events 5 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	2.6% 1/38 • Number of events 1 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Dyspepsia	2.6% 1/39 • Number of events 1 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	18.9% 7/37 • Number of events 13 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.3% 2/38 • Number of events 6 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Flatulence	5.1% 2/39 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	10.8% 4/37 • Number of events 5 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.3% 2/38 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	8.1% 3/37 • Number of events 3 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	7.9% 3/38 • Number of events 4 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Nausea	5.1% 2/39 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	51.4% 19/37 • Number of events 49 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	28.9% 11/38 • Number of events 14 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Gastrointestinal disorders Vomiting	2.6% 1/39 • Number of events 1 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	29.7% 11/37 • Number of events 16 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	10.5% 4/38 • Number of events 6 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
General disorders Fatigue	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.4% 2/37 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	0.00% 0/38 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
General disorders Injection site bruising	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	0.00% 0/37 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.3% 2/38 • Number of events 9 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
General disorders Injection site pain	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	2.7% 1/37 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.3% 2/38 • Number of events 4 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
General disorders Injection site reaction	2.6% 1/39 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	10.8% 4/37 • Number of events 7 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	2.6% 1/38 • Number of events 3 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Infections and infestations COVID-19	5.1% 2/39 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.4% 2/37 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	0.00% 0/38 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/39 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	5.4% 2/37 • Number of events 2 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	0.00% 0/38 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
Nervous system disorders Headache	7.7% 3/39 • Number of events 5 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	18.9% 7/37 • Number of events 15 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.	7.9% 3/38 • Number of events 3 • Baseline up to 10 Weeks All randomized participants who received at least 1 dose of the study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.