Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin (NCT NCT04039503)

Last Updated: 2022-01-12

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 + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

475 participants

Primary outcome timeframe

Baseline, Week 40

Results posted on

2022-01-12

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.	Placebo Placebo administered SC once a week.
Overall Study STARTED	116	119	120	120
Overall Study Received at Least One Dose of Study Drug	116	119	120	120
Overall Study COMPLETED	109	115	110	117
Overall Study NOT COMPLETED	7	4	10	3

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.	Placebo Placebo administered SC once a week.
Overall Study Adverse Event	3	0	2	0
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Protocol Violation	0	1	2	1
Overall Study Withdrawal by Subject	4	3	5	2

Baseline Characteristics

A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5 mg Tirzepatide n=116 Participants 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide n=119 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=120 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=120 Participants Placebo administered SC once a week.	Total n=475 Participants Total of all reporting groups
Age, Continuous	61.50 years STANDARD_DEVIATION 9.81 • n=5 Participants	60.40 years STANDARD_DEVIATION 10.24 • n=7 Participants	60.50 years STANDARD_DEVIATION 9.92 • n=5 Participants	60.00 years STANDARD_DEVIATION 9.63 • n=4 Participants	60.60 years STANDARD_DEVIATION 9.88 • n=21 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	47 Participants n=7 Participants	55 Participants n=5 Participants	54 Participants n=4 Participants	211 Participants n=21 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	72 Participants n=7 Participants	65 Participants n=5 Participants	66 Participants n=4 Participants	264 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	95 Participants n=7 Participants	93 Participants n=5 Participants	98 Participants n=4 Participants	380 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants	16 Participants n=7 Participants	22 Participants n=5 Participants	17 Participants n=4 Participants	73 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	22 Participants n=4 Participants	85 Participants n=21 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	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	95 Participants n=5 Participants	94 Participants n=7 Participants	94 Participants n=5 Participants	97 Participants n=4 Participants	380 Participants n=21 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	2 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 Czechia	24 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	23 Participants n=4 Participants	94 Participants n=21 Participants
Region of Enrollment Germany	32 Participants n=5 Participants	32 Participants n=7 Participants	33 Participants n=5 Participants	32 Participants n=4 Participants	129 Participants n=21 Participants
Region of Enrollment Japan	19 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	22 Participants n=4 Participants	82 Participants n=21 Participants
Region of Enrollment Poland	8 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	36 Participants n=21 Participants
Region of Enrollment Puerto Rico	2 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants
Region of Enrollment Slovakia	8 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	31 Participants n=21 Participants
Region of Enrollment Spain	13 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	14 Participants n=4 Participants	57 Participants n=21 Participants
Region of Enrollment United States	10 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	34 Participants n=21 Participants
Hemoglobin A1c	8.30 Percentage of HbA1c STANDARD_DEVIATION 0.88 • n=5 Participants	8.36 Percentage of HbA1c STANDARD_DEVIATION 0.83 • n=7 Participants	8.23 Percentage of HbA1c STANDARD_DEVIATION 0.86 • n=5 Participants	8.37 Percentage of HbA1c STANDARD_DEVIATION 0.84 • n=4 Participants	8.31 Percentage of HbA1c STANDARD_DEVIATION 0.85 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 40

Population: All randomized participants from who received at least 1 dose study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing 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=113 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=117 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.	Placebo Placebo administered SC once a week.
Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)	-2.59 Percentage of HbA1c Standard Error 0.081	-2.59 Percentage of HbA1c Standard Error 0.083	-0.93 Percentage of HbA1c Standard Error 0.079	—

SECONDARY outcome

Timeframe: Baseline, Week 40

Population: All randomized participants who received at least one dose of 5 mg tirzepatide, placebo and had a baseline and at least 1 post-baseline value, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=118 Participants 15 mg tirzepatide administered SC once a week.	Placebo Placebo administered SC once a week.	Placebo Placebo administered SC once a week.
Change From Baseline in HbA1c (5 mg)	-2.23 Percentage of HbA1c Standard Error 0.081	-0.93 Percentage of HbA1c Standard Error 0.079	—	—

SECONDARY outcome

Timeframe: Baseline, Week 40

Population: All randomly assigned participants who took at least 1 dose of study drug and had a baseline and at least 1 post-baseline value, excluding patients discontinuing 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 + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=113 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=117 Participants Placebo administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.
Change From Baseline in Body Weight	-6.2 Kilograms (kg) Standard Error 0.58	-8.2 Kilograms (kg) Standard Error 0.58	-10.9 Kilograms (kg) Standard Error 0.59	1.7 Kilograms (kg) Standard Error 0.57

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=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=113 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=117 Participants Placebo administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.
Percentage of Participants Achieving an HbA1c Target Value of <7%	93.04 Percentage of Participants	97.35 Percentage of Participants	94.02 Percentage of Participants	33.90 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 40

Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS Mean was determined by MMRM model with Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=116 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.
Change From Baseline in Fasting Serum Glucose	-61.4 milligram per Deciliter (mg/dL) Standard Error 2.55	-67.9 milligram per Deciliter (mg/dL) Standard Error 2.55	-67.7 milligram per Deciliter (mg/dL) Standard Error 2.64	-38.9 milligram per Deciliter (mg/dL) Standard Error 2.49

SECONDARY outcome

Timeframe: Baseline, Week 40

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 + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment (Type III sum of squares).

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=100 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=99 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=94 Participants Placebo administered SC once a week.	Placebo n=97 Participants Placebo administered SC once a week.
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values	-67.1 mg/dL Standard Error 2.05	-71.7 mg/dL Standard Error 2.04	-73.7 mg/dL Standard Error 2.10	-39.4 mg/dL Standard Error 2.07

SECONDARY outcome

Timeframe: Week 40

Percentage of Participants who Achieved Weight Loss ≥5%.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=113 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=117 Participants Placebo administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.
Percentage of Participants Who Achieved Weight Loss ≥5%	53.91 Percentage of Participants	64.60 Percentage of Participants	84.62 Percentage of Participants	5.93 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 40

LS mean was calculated using MMRM model with log (Baseline) + Baseline Metformin Use (Yes, No) + Pooled Country + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=105 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=103 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=96 Participants Placebo administered SC once a week.	Placebo n=111 Participants Placebo administered SC once a week.
Percentage Change From Baseline in Daily Mean Insulin Glargine Dose	13.0 International Units (IU) Standard Error 7.34	8.1 International Units (IU) Standard Error 7.03	-11.4 International Units (IU) Standard Error 5.85	75.0 International Units (IU) Standard Error 11.11

SECONDARY outcome

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

Population: All randomly assigned participants who took at least 1 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 Metformin Use (Yes, No) + Baseline HbA1c Group (\<= 8.0%, \>8.0%) + Treatment, with log (exposure in days/365.25) as an offset variable.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=116 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=119 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=120 Participants Placebo administered SC once a week.	Placebo n=120 Participants Placebo 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	0.49 Episodes/participant/365.25 days Standard Error 0.141	0.66 Episodes/participant/365.25 days Standard Error 0.169	0.38 Episodes/participant/365.25 days Standard Error 0.099	0.51 Episodes/participant/365.25 days Standard Error 0.149

SECONDARY outcome

Timeframe: Week 7, 15, 23 and 39 post dose

Population: All randomized participants who received at least one dose and had evaluable PK data.

AUC is a combined measure obtained from Week 7, 15, 23 and 39 and a single averaged measure of AUC was reported.

Outcome measures

Outcome measures
Measure	10 mg Tirzepatide n=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=116 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.	Placebo Placebo administered SC once a week.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide	79700 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 24.5	164000 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 26.7	246000 nanogramhour per milliliter (ngh/mL) Geometric Coefficient of Variation 26.4	—

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=115 Participants 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=113 Participants 15 mg tirzepatide administered SC once a week.	Placebo n=117 Participants Placebo administered SC once a week.	Placebo n=118 Participants Placebo administered SC once a week.
Percentage of Participants Achieving an HbA1c Target Value of <5.7%	26.09 Percentage of Participants	47.79 Percentage of Participants	62.39 Percentage of Participants	2.54 Percentage of Participants

Adverse Events

5 mg Tirzepatide

Serious events: 9 serious events

Other events: 52 other events

Deaths: 0 deaths

10 mg Tirzepatide

Serious events: 13 serious events

Other events: 60 other events

Deaths: 0 deaths

15 mg Tirzepatide

Serious events: 9 serious events

Other events: 67 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	5 mg Tirzepatide n=116 participants at risk 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	10 mg Tirzepatide n=119 participants at risk 10 mg tirzepatide administered SC once a week.	15 mg Tirzepatide n=120 participants at risk 15 mg tirzepatide administered SC once a week.	Placebo n=120 participants at risk Placebo administered SC once a week.
Gastrointestinal disorders Constipation	6.0% 7/116 • Number of events 7 • Baseline, 17 Months 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.	6.7% 8/119 • Number of events 8 • Baseline, 17 Months 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.	6.7% 8/120 • Number of events 9 • Baseline, 17 Months 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.	1.7% 2/120 • Number of events 2 • Baseline, 17 Months 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	12.1% 14/116 • Number of events 22 • Baseline, 17 Months 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.	12.6% 15/119 • Number of events 46 • Baseline, 17 Months 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.	20.8% 25/120 • Number of events 44 • Baseline, 17 Months 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.	10.0% 12/120 • Number of events 12 • Baseline, 17 Months 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	6.9% 8/116 • Number of events 9 • Baseline, 17 Months 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.	8.4% 10/119 • Number of events 12 • Baseline, 17 Months 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.	5.0% 6/120 • Number of events 6 • Baseline, 17 Months 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.	1.7% 2/120 • Number of events 2 • Baseline, 17 Months 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 Eructation	5.2% 6/116 • Number of events 11 • Baseline, 17 Months 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.	3.4% 4/119 • Number of events 16 • Baseline, 17 Months 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% 7/120 • Number of events 11 • Baseline, 17 Months 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.	0.83% 1/120 • Number of events 1 • Baseline, 17 Months 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 Flatulence	2.6% 3/116 • Number of events 3 • Baseline, 17 Months 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.	5.0% 6/119 • Number of events 21 • Baseline, 17 Months 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% 7/120 • Number of events 12 • Baseline, 17 Months 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.	0.00% 0/120 • Baseline, 17 Months 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	12.9% 15/116 • Number of events 26 • Baseline, 17 Months 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.	17.6% 21/119 • Number of events 43 • Baseline, 17 Months 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.	18.3% 22/120 • Number of events 44 • Baseline, 17 Months 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.	2.5% 3/120 • Number of events 3 • Baseline, 17 Months 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	6.9% 8/116 • Number of events 12 • Baseline, 17 Months 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.	7.6% 9/119 • Number of events 18 • Baseline, 17 Months 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.	12.5% 15/120 • Number of events 26 • Baseline, 17 Months 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.	2.5% 3/120 • Number of events 3 • Baseline, 17 Months 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.
Infections and infestations Nasopharyngitis	15.5% 18/116 • Number of events 23 • Baseline, 17 Months 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.	6.7% 8/119 • Number of events 11 • Baseline, 17 Months 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.	12.5% 15/120 • Number of events 19 • Baseline, 17 Months 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% 23/120 • Number of events 27 • Baseline, 17 Months 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.
Investigations Lipase increased	3.4% 4/116 • Number of events 4 • Baseline, 17 Months 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.	1.7% 2/119 • Number of events 2 • Baseline, 17 Months 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% 10/120 • Number of events 12 • Baseline, 17 Months 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.	1.7% 2/120 • Number of events 2 • Baseline, 17 Months 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	6.9% 8/116 • Number of events 8 • Baseline, 17 Months 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.	12.6% 15/119 • Number of events 17 • Baseline, 17 Months 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.	14.2% 17/120 • Number of events 21 • Baseline, 17 Months 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.	1.7% 2/120 • Number of events 2 • Baseline, 17 Months 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 Hyperglycaemia	1.7% 2/116 • Number of events 2 • Baseline, 17 Months 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.	0.00% 0/119 • Baseline, 17 Months 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.	0.83% 1/120 • Number of events 1 • Baseline, 17 Months 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.	13.3% 16/120 • Number of events 18 • Baseline, 17 Months 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.
Musculoskeletal and connective tissue disorders Arthralgia	5.2% 6/116 • Number of events 7 • Baseline, 17 Months 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.	3.4% 4/119 • Number of events 4 • Baseline, 17 Months 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.	2.5% 3/120 • Number of events 3 • Baseline, 17 Months 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.	1.7% 2/120 • Number of events 2 • Baseline, 17 Months 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.
Musculoskeletal and connective tissue disorders Back pain	5.2% 6/116 • Number of events 8 • Baseline, 17 Months 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.	5.0% 6/119 • Number of events 7 • Baseline, 17 Months 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.	3.3% 4/120 • Number of events 6 • Baseline, 17 Months 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% 7/120 • Number of events 7 • Baseline, 17 Months 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.
Vascular disorders Hypertension	2.6% 3/116 • Number of events 3 • Baseline, 17 Months 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.	2.5% 3/119 • Number of events 3 • Baseline, 17 Months 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.	0.83% 1/120 • Number of events 1 • Baseline, 17 Months 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% 7/120 • Number of events 7 • Baseline, 17 Months 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