Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes (NCT NCT03987919)

Last Updated: 2022-02-14

Results Overview

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1879 participants

Primary outcome timeframe

Baseline, Week 40

Results posted on

2022-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	5 mg Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide 1 mg semaglutide administered SC once a week.
Overall Study STARTED	471	469	470	469
Overall Study Received at Least One Dose of Study Drug	470	469	470	469
Overall Study COMPLETED	452	442	446	443
Overall Study NOT COMPLETED	19	27	24	26

Reasons for withdrawal

Reasons for withdrawal
Measure	5 mg Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide 1 mg semaglutide administered SC once a week.
Overall Study Adverse Event	1	4	1	3
Overall Study Death	4	4	4	1
Overall Study Lost to Follow-up	5	6	8	12
Overall Study Physician Decision	0	2	0	4
Overall Study Pregnancy	1	0	1	1
Overall Study Protocol Violation	0	1	0	0
Overall Study Site terminated by Sponsor	0	0	0	1
Overall Study Withdrawal by Subject	7	7	8	4
Overall Study Other - as reported by the investigator	1	3	2	0

Baseline Characteristics

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5 mg Tirzepatide n=470 Participants 5 mg tirzepatide administered SC once a week.	10 mg Tirzepatide n=469 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=470 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=469 Participants 1 mg semaglutide administered SC once a week.	Total n=1878 Participants Total of all reporting groups
Age, Continuous	56.3 years STANDARD_DEVIATION 10.0 • n=5 Participants	57.2 years STANDARD_DEVIATION 10.5 • n=7 Participants	55.9 years STANDARD_DEVIATION 10.4 • n=5 Participants	56.9 years STANDARD_DEVIATION 10.8 • n=4 Participants	56.6 years STANDARD_DEVIATION 10.4 • n=21 Participants
Sex: Female, Male Female	265 Participants n=5 Participants	231 Participants n=7 Participants	256 Participants n=5 Participants	244 Participants n=4 Participants	996 Participants n=21 Participants
Sex: Female, Male Male	205 Participants n=5 Participants	238 Participants n=7 Participants	214 Participants n=5 Participants	225 Participants n=4 Participants	882 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	325 Participants n=5 Participants	322 Participants n=7 Participants	334 Participants n=5 Participants	336 Participants n=4 Participants	1317 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=5 Participants	147 Participants n=7 Participants	136 Participants n=5 Participants	133 Participants n=4 Participants	561 Participants n=21 Participants
Ethnicity (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	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	53 Participants n=5 Participants	53 Participants n=7 Participants	57 Participants n=5 Participants	45 Participants n=4 Participants	208 Participants n=21 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	79 Participants n=21 Participants
Race (NIH/OMB) White	382 Participants n=5 Participants	376 Participants n=7 Participants	392 Participants n=5 Participants	401 Participants n=4 Participants	1551 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 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	0 Participants n=21 Participants
Region of Enrollment Argentina	158 Participants n=5 Participants	160 Participants n=7 Participants	161 Participants n=5 Participants	161 Participants n=4 Participants	640 Participants n=21 Participants
Region of Enrollment Australia	12 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	46 Participants n=21 Participants
Region of Enrollment Brazil	37 Participants n=5 Participants	37 Participants n=7 Participants	36 Participants n=5 Participants	37 Participants n=4 Participants	147 Participants n=21 Participants
Region of Enrollment Canada	15 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	15 Participants n=4 Participants	59 Participants n=21 Participants
Region of Enrollment Israel	22 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	21 Participants n=4 Participants	87 Participants n=21 Participants
Region of Enrollment Mexico	89 Participants n=5 Participants	87 Participants n=7 Participants	88 Participants n=5 Participants	88 Participants n=4 Participants	352 Participants n=21 Participants
Region of Enrollment Puerto Rico	6 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	19 Participants n=21 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	72 Participants n=21 Participants
Region of Enrollment United States	113 Participants n=5 Participants	115 Participants n=7 Participants	113 Participants n=5 Participants	115 Participants n=4 Participants	456 Participants n=21 Participants
Hemoglobin A1c	8.32 Percentage of HbA1c STANDARD_DEVIATION 1.08 • n=5 Participants	8.30 Percentage of HbA1c STANDARD_DEVIATION 1.02 • n=7 Participants	8.26 Percentage of HbA1c STANDARD_DEVIATION 1.00 • n=5 Participants	8.25 Percentage of HbA1c STANDARD_DEVIATION 1.01 • n=4 Participants	8.28 Percentage of HbA1c STANDARD_DEVIATION 1.03 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 40

Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=459 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=464 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=461 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide 1 mg of semaglutide administered SC once a week.
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)	-2.37 Percentage of HbA1c Standard Error 0.048	-2.46 Percentage of HbA1c Standard Error 0.048	-1.86 Percentage of HbA1c Standard Error 0.048	—

SECONDARY outcome

Timeframe: Baseline, Week 40

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=461 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=461 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide 1 mg semaglutide administered SC once a week.	1 mg Semaglutide 1 mg of semaglutide administered SC once a week.
Change From Baseline in HbA1c (5 mg)	-2.09 Percentage of HbA1c Standard Error 0.047	-1.86 Percentage of HbA1c Standard Error 0.048	—	—

SECONDARY outcome

Timeframe: Baseline, Week 40

Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline body weight value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=461 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=459 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=464 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=462 Participants 1 mg of semaglutide administered SC once a week.
Change From Baseline in Body Weight	-7.8 Kilograms (kg) Standard Error 0.33	-10.3 Kilograms (kg) Standard Error 0.34	-12.4 Kilograms (kg) Standard Error 0.34	-6.2 Kilograms (kg) Standard Error 0.33

SECONDARY outcome

Timeframe: Week 40

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=461 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=459 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=464 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=461 Participants 1 mg of semaglutide administered SC once a week.
Percentage of Participants Achieving an HbA1c Target Value of <7%	85.47 Percentage of Participants	88.89 Percentage of Participants	92.24 Percentage of Participants	81.13 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 40

Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline FSG value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=461 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=458 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=464 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=459 Participants 1 mg of semaglutide administered SC once a week.
Change From Baseline in Fasting Serum Glucose (FSG)	-56.0 milligram per Deciliter (mg/dL) Standard Error 1.57	-61.6 milligram per Deciliter (mg/dL) Standard Error 1.60	-63.4 milligram per Deciliter (mg/dL) Standard Error 1.59	-48.6 milligram per Deciliter (mg/dL) Standard Error 1.58

SECONDARY outcome

Timeframe: Baseline, Week 40

Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline SMBG value, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=424 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=412 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=413 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=414 Participants 1 mg of semaglutide administered SC once a week.
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values	-65.4 mg/dL Standard Error 1.04	-70.6 mg/dL Standard Error 1.05	-74.3 mg/dL Standard Error 1.05	-61.4 mg/dL Standard Error 1.04

SECONDARY outcome

Timeframe: Week 40

Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline weight loss, excluding patients who discontinued study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

Percentage of Participants who Achieved Weight Loss ≥5%.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=461 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=459 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=464 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=462 Participants 1 mg of semaglutide administered SC once a week.
Percentage of Participants Who Achieved Weight Loss ≥5%	68.55 Percentage of Participants	82.35 Percentage of Participants	86.21 Percentage of Participants	58.44 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 40

Population: All randomized participants who received at least one dose of study drug. Last observation carried forward (LOCF) endpoint only carries forward the last non-baseline observations before rescue therapy or stopping study drug.

DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS Mean was determined by ANCOVA with Baseline DTSQs + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=419 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=399 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=398 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=412 Participants 1 mg of semaglutide administered SC once a week.
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score Hyperglycemia	-1.3 Units on a Scale Standard Error 0.10	-1.4 Units on a Scale Standard Error 0.10	-1.5 Units on a Scale Standard Error 0.10	-1.1 Units on a Scale Standard Error 0.10
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score Hypoglycemia	-0.7 Units on a Scale Standard Error 0.10	-0.7 Units on a Scale Standard Error 0.10	-0.8 Units on a Scale Standard Error 0.10	-0.7 Units on a Scale Standard Error 0.10
Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Total Score Total Score	15.7 Units on a Scale Standard Error 0.18	15.6 Units on a Scale Standard Error 0.19	16.1 Units on a Scale Standard Error 0.19	15.8 Units on a Scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline through Safety Follow-Up (Up to Week 44)

Population: All randomized participants who received at least one dose of study drug.

The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL) (\<3.0 mmol/L\] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of postbaseline hypoglycemia was estimated by negative binomial model: number of episodes = Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Treatment.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=470 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=469 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=470 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=469 Participants 1 mg of semaglutide administered SC once a week.
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 Millimole/Liter (mmol/L)] or Severe Hypoglycemia	0.0102 Episodes/participant/365.25 days Standard Error 0.00423	0.0046 Episodes/participant/365.25 days Standard Error 0.00488	0.0202 Episodes/participant/365.25 days Standard Error 0.00840	0.0046 Episodes/participant/365.25 days Standard Error 0.00340

SECONDARY outcome

Timeframe: Week 40

Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug

Percentage of Participants Achieving an HbA1c Target Value of \<5.7%.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=461 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=459 Participants 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=464 Participants 1 mg semaglutide administered SC once a week.	1 mg Semaglutide n=461 Participants 1 mg of semaglutide administered SC once a week.
Percentage of Participants Achieving an HbA1c Target Value of <5.7%	29.28 Percentage of Participants	44.66 Percentage of Participants	50.86 Percentage of Participants	19.74 Percentage of Participants

Adverse Events

5 mg Tirzepatide

Serious events: 33 serious events

Other events: 170 other events

Deaths: 4 deaths

10 mg Tirzepatide

Serious events: 25 serious events

Other events: 187 other events

Deaths: 4 deaths

15 mg Tirzepatide

Serious events: 27 serious events

Other events: 202 other events

Deaths: 4 deaths

1 mg Semaglutide

Serious events: 13 serious events

Other events: 172 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	5 mg Tirzepatide n=470 participants at risk 5 mg tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide n=469 participants at risk 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=470 participants at risk 15 mg tirzepatide administered SC once a week.	1 mg Semaglutide n=469 participants at risk 1 mg of semaglutide administered SC once a week.
Gastrointestinal disorders Abdominal pain	3.0% 14/470 • Number of events 16 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.3% 20/469 • Number of events 25 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 24/470 • Number of events 30 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.1% 24/469 • Number of events 29 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	6.6% 31/470 • Number of events 35 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 21/469 • Number of events 23 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	4.5% 21/470 • Number of events 23 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.8% 27/469 • Number of events 32 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	13.2% 62/470 • Number of events 120 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	16.4% 77/469 • Number of events 98 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	13.8% 65/470 • Number of events 102 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	11.5% 54/469 • Number of events 68 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	7.2% 34/470 • Number of events 46 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.2% 29/469 • Number of events 43 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.1% 43/470 • Number of events 51 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	6.6% 31/469 • Number of events 42 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	17.4% 82/470 • Number of events 110 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	19.2% 90/469 • Number of events 121 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	22.1% 104/470 • Number of events 136 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	17.9% 84/469 • Number of events 126 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	5.7% 27/470 • Number of events 35 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 39/469 • Number of events 54 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	9.8% 46/470 • Number of events 61 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.3% 39/469 • Number of events 53 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	7.4% 35/470 • Number of events 38 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	7.2% 34/469 • Number of events 43 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	8.9% 42/470 • Number of events 51 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	5.3% 25/469 • Number of events 26 • Baseline, Safety follow-up (44 Weeks) All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60