Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk (NCT NCT03730662)

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 for post-baseline measures: Variable = Baseline + Pooled Country + Baseline sodium-glucose co-transporter-2 inhibitor (SGLT-2i) use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2002 participants

Primary outcome timeframe

Baseline, Week 52

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.	Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Treatment Period (52 Weeks) STARTED	329	330	338	1005
Treatment Period (52 Weeks) Received at Least One Dose of Study Drug	329	328	338	1000
Treatment Period (52 Weeks) COMPLETED	308	319	329	953
Treatment Period (52 Weeks) NOT COMPLETED	21	11	9	52
Variable Treatment Period STARTED	308	319	329	953
Variable Treatment Period COMPLETED	294	312	313	882
Variable Treatment Period NOT COMPLETED	14	7	16	71

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.	Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Treatment Period (52 Weeks) Adverse Event	3	2	0	3
Treatment Period (52 Weeks) Screen Failure	0	1	0	0
Treatment Period (52 Weeks) Death	6	2	2	9
Treatment Period (52 Weeks) Lost to Follow-up	4	2	2	11
Treatment Period (52 Weeks) Physician Decision	1	1	0	3
Treatment Period (52 Weeks) Protocol Violation	0	1	0	1
Treatment Period (52 Weeks) Withdrawal by Subject	5	0	5	23
Treatment Period (52 Weeks) Personal Reason	2	2	0	2
Variable Treatment Period Adverse Event	1	2	0	7
Variable Treatment Period Death	9	0	6	26
Variable Treatment Period Lost to Follow-up	2	1	4	11
Variable Treatment Period Personal Reason	0	2	1	6
Variable Treatment Period Physician Decision	0	0	0	3
Variable Treatment Period Protocol Violation	0	1	1	1
Variable Treatment Period Withdrawal by Subject	2	1	4	17

Baseline Characteristics

A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5 mg Tirzepatide n=329 Participants 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide n=330 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=338 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=1005 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Total n=2002 Participants Total of all reporting groups
Age, Continuous	62.90 years STANDARD_DEVIATION 8.56 • n=5 Participants	63.70 years STANDARD_DEVIATION 8.68 • n=7 Participants	63.70 years STANDARD_DEVIATION 8.60 • n=5 Participants	63.80 years STANDARD_DEVIATION 8.51 • n=4 Participants	63.60 years STANDARD_DEVIATION 8.56 • n=21 Participants
Sex: Female, Male Female	131 Participants n=5 Participants	121 Participants n=7 Participants	135 Participants n=5 Participants	364 Participants n=4 Participants	751 Participants n=21 Participants
Sex: Female, Male Male	198 Participants n=5 Participants	209 Participants n=7 Participants	203 Participants n=5 Participants	641 Participants n=4 Participants	1251 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	154 Participants n=5 Participants	164 Participants n=7 Participants	155 Participants n=5 Participants	478 Participants n=4 Participants	951 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	172 Participants n=5 Participants	164 Participants n=7 Participants	179 Participants n=5 Participants	521 Participants n=4 Participants	1036 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	32 Participants n=5 Participants	30 Participants n=7 Participants	26 Participants n=5 Participants	86 Participants n=4 Participants	174 Participants n=21 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	31 Participants n=4 Participants	70 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants	76 Participants n=21 Participants
Race (NIH/OMB) White	260 Participants n=5 Participants	260 Participants n=7 Participants	285 Participants n=5 Participants	827 Participants n=4 Participants	1632 Participants n=21 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	24 Participants n=4 Participants	43 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment Argentina	80 Participants n=5 Participants	80 Participants n=7 Participants	82 Participants n=5 Participants	242 Participants n=4 Participants	484 Participants n=21 Participants
Region of Enrollment Australia	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants	19 Participants n=21 Participants
Region of Enrollment Brazil	42 Participants n=5 Participants	41 Participants n=7 Participants	42 Participants n=5 Participants	125 Participants n=4 Participants	250 Participants n=21 Participants
Region of Enrollment Canada	8 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	27 Participants n=4 Participants	51 Participants n=21 Participants
Region of Enrollment Greece	7 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants	38 Participants n=21 Participants
Region of Enrollment Israel	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants	29 Participants n=21 Participants
Region of Enrollment Mexico	27 Participants n=5 Participants	27 Participants n=7 Participants	26 Participants n=5 Participants	80 Participants n=4 Participants	160 Participants n=21 Participants
Region of Enrollment Poland	27 Participants n=5 Participants	25 Participants n=7 Participants	26 Participants n=5 Participants	78 Participants n=4 Participants	156 Participants n=21 Participants
Region of Enrollment Romania	13 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants	82 Participants n=21 Participants
Region of Enrollment Russia	14 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants	88 Participants n=21 Participants
Region of Enrollment Slovakia	33 Participants n=5 Participants	32 Participants n=7 Participants	34 Participants n=5 Participants	100 Participants n=4 Participants	199 Participants n=21 Participants
Region of Enrollment Spain	11 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants	77 Participants n=21 Participants
Region of Enrollment Taiwan	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment United States	55 Participants n=5 Participants	56 Participants n=7 Participants	57 Participants n=5 Participants	171 Participants n=4 Participants	339 Participants n=21 Participants
Hemoglobin A1c	8.52 Percentage of HbA1c STANDARD_DEVIATION 0.84 • n=5 Participants	8.59 Percentage of HbA1c STANDARD_DEVIATION 0.91 • n=7 Participants	8.52 Percentage of HbA1c STANDARD_DEVIATION 0.98 • n=5 Participants	8.50 Percentage of HbA1c STANDARD_DEVIATION 0.85 • n=4 Participants	8.52 Percentage of HbA1c STANDARD_DEVIATION 0.88 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline value, excluding participants discontinuing study drug due to inadvertent enrollment

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=289 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=291 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=887 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)	-2.43 Percentage of HbA1c Standard Error 0.053	-2.58 Percentage of HbA1c Standard Error 0.053	-1.44 Percentage of HbA1c Standard Error 0.030	—

SECONDARY outcome

Timeframe: Baseline, Week 52

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=283 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=887 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Change From Baseline in HbA1c (5 mg)	-2.24 Percentage of HbA1c Standard Error 0.053	-1.44 Percentage of HbA1c Standard Error 0.030	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=285 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=288 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=291 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine n=891 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Change From Baseline in Body Weight	-7.1 Kilograms (kg) Standard Error 0.34	-9.5 Kilograms (kg) Standard Error 0.34	-11.7 Kilograms (kg) Standard Error 0.33	1.9 Kilograms (kg) Standard Error 0.19

SECONDARY outcome

Timeframe: Week 52

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=326 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=321 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=334 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine n=978 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Percentage of Participants With HbA1c of <7.0%	80.98 percentage of participants	88.16 percentage of participants	90.72 percentage of participants	50.72 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=281 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=283 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=288 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine n=880 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Change From Baseline in Fasting Serum Glucose	-50.4 milligram per Deciliter (mg/dL) Standard Error 2.07	-54.9 milligram per Deciliter (mg/dL) Standard Error 2.06	-59.3 milligram per Deciliter (mg/dL) Standard Error 2.04	-51.4 milligram per Deciliter (mg/dL) Standard Error 1.17

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: All randomized participants who received at least one dose of study drug, excluding participants discontinuing study drug due to inadvertent enrollment

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. LS mean was determined by mixed-model repeated measures (MMRM) model with variables Baseline + Pooled Country + Baseline HbA1c Group (\<=8.5%, \>8.5%) + Baseline SGLT-2i use Flag (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=265 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=261 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=265 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine n=784 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values	-58.4 mg/dL Standard Error 1.65	-61.1 mg/dL Standard Error 1.66	-66.1 mg/dL Standard Error 1.66	-46.1 mg/dL Standard Error 0.96

SECONDARY outcome

Timeframe: 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours post dose of Week 7, 15, 23, 35

Population: Pharmacokinetic samples were collected from atleast the first 150 participants at each Tirzepatide dose, all participants aged ≥70 years, and all participants with severe renal impairment or end-stage renal disease (ESRD) (estimated glomerular filtration rate \[eGFR\] \<30 mL/min)

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=326 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=324 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=334 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve From Zero to Tau (AUC 0-Tau) of Tirzepatide	81800 Nanograms per millilitre per hour Geometric Coefficient of Variation 23.9	165000 Nanograms per millilitre per hour Geometric Coefficient of Variation 20.3	246000 Nanograms per millilitre per hour Geometric Coefficient of Variation 20.6	—

SECONDARY outcome

Timeframe: Baseline through Week 52

Population: All randomized participants who received at least one dose of study drug, excluding participants hypoglycemic events occurring after initiation of a new antihyperglycemic therapy

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. Post-baseline comparisons between treatment and control group was evaluated using negative binomial model with variables : Number of episodes = Baseline HbA1c Group (\<=8.5%, \>8.5%) + Pooled Country + Baseline SGLT-2i use Flag (Yes, No) + Treatment, with log (exposure in days/365.25) as an offset variable

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=329 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=328 Participants 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=338 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.	Insulin Glargine n=1000 Participants Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Rate of Hypoglycemia With Blood Glucose <54 Milligram/Deciliter (mg/dL) [<3.0 (Millimole/Liter (mmol/L))] or Severe Hypoglycemia	0.10 Episodes/participant/365.25 days Standard Error 0.023	0.09 Episodes/participant/365.25 days Standard Error 0.025	0.11 Episodes/participant/365.25 days Standard Error 0.030	0.35 Episodes/participant/365.25 days Standard Error 0.044

Adverse Events

5 mg Tirzepatide

Serious events: 48 serious events

Other events: 112 other events

Deaths: 15 deaths

10 mg Tirzepatide

Serious events: 54 serious events

Other events: 158 other events

Deaths: 2 deaths

15 mg Tirzepatide

Serious events: 41 serious events

Other events: 184 other events

Deaths: 8 deaths

Insulin Glargine

Serious events: 193 serious events

Other events: 192 other events

Deaths: 35 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	5 mg Tirzepatide n=329 participants at risk 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide n=328 participants at risk 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=338 participants at risk 15 mg tirzepatide administered SC once a week.	Insulin Glargine n=1000 participants at risk Insulin glargine administered SC once a day. Doses were individualized and titrated according to protocol-defined targets. The starting dose of insulin glargine was 10 IU/day at bedtime, titrated to a FBG \<100 mg/dL, following a treat-to-target (TTT) algorithm.
Gastrointestinal disorders Constipation	5.2% 17/329 • Number of events 17 • Baseline Up To 2 Years All 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% 14/328 • Number of events 15 • Baseline Up To 2 Years All 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.	4.1% 14/338 • Number of events 14 • Baseline Up To 2 Years All 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.	0.50% 5/1000 • Number of events 5 • Baseline Up To 2 Years All 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	12.5% 41/329 • Number of events 68 • Baseline Up To 2 Years All 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.	19.8% 65/328 • Number of events 128 • Baseline Up To 2 Years All 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.	21.9% 74/338 • Number of events 118 • Baseline Up To 2 Years All 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.	4.4% 44/1000 • Number of events 50 • Baseline Up To 2 Years All 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	5.5% 18/329 • Number of events 23 • Baseline Up To 2 Years All 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.	8.2% 27/328 • Number of events 36 • Baseline Up To 2 Years All 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.	7.7% 26/338 • Number of events 36 • Baseline Up To 2 Years All 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.	1.3% 13/1000 • Number of events 13 • Baseline Up To 2 Years All 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	11.9% 39/329 • Number of events 104 • Baseline Up To 2 Years All 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.	16.2% 53/328 • Number of events 91 • Baseline Up To 2 Years All 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.	22.5% 76/338 • Number of events 157 • Baseline Up To 2 Years All 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.	2.3% 23/1000 • Number of events 29 • Baseline Up To 2 Years All 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	4.9% 16/329 • Number of events 18 • Baseline Up To 2 Years All 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.	8.2% 27/328 • Number of events 43 • Baseline Up To 2 Years All 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.	8.6% 29/338 • Number of events 62 • Baseline Up To 2 Years All 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.	1.5% 15/1000 • Number of events 16 • Baseline Up To 2 Years All 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.
Infections and infestations Covid-19	4.0% 13/329 • Number of events 14 • Baseline Up To 2 Years All 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.	3.7% 12/328 • Number of events 12 • Baseline Up To 2 Years All 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.	5.0% 17/338 • Number of events 17 • Baseline Up To 2 Years All 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.	4.9% 49/1000 • Number of events 49 • Baseline Up To 2 Years All 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.
Infections and infestations Nasopharyngitis	3.0% 10/329 • Number of events 11 • Baseline Up To 2 Years All 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.	4.9% 16/328 • Number of events 17 • Baseline Up To 2 Years All 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.	4.7% 16/338 • Number of events 19 • Baseline Up To 2 Years All 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.	6.5% 65/1000 • Number of events 70 • Baseline Up To 2 Years All 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.
Investigations Lipase increased	3.0% 10/329 • Number of events 11 • Baseline Up To 2 Years All 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.	4.0% 13/328 • Number of events 15 • Baseline Up To 2 Years All 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% 21/338 • Number of events 25 • Baseline Up To 2 Years All 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.	1.8% 18/1000 • Number of events 18 • Baseline Up To 2 Years All 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	8.8% 29/329 • Number of events 36 • Baseline Up To 2 Years All 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.	11.0% 36/328 • Number of events 46 • Baseline Up To 2 Years All 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.	10.4% 35/338 • Number of events 43 • Baseline Up To 2 Years All 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.	0.50% 5/1000 • Number of events 5 • Baseline Up To 2 Years All 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