Trial Outcomes & Findings for A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH) (NCT NCT05564039)

Last Updated: 2025-08-03

Results Overview

HbA1c is the glycated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

282 participants

Primary outcome timeframe

Baseline, Week 40

Results posted on

2025-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD) Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Overall Study STARTED	139	143
Overall Study Received at Least 1 Dose of Study Drug	139	143
Overall Study COMPLETED	129	134
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Reasons for withdrawal
Measure	15 Milligram (mg) Tirzepatide or Maximum Tolerated Dose (MTD) Participants received tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Overall Study Adverse Event	1	0
Overall Study Death	1	1
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	2	0
Overall Study Inadvertent enrollment	3	6

Baseline Characteristics

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	15 mg Tirzepatide or MTD n=139 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=143 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.	Total n=282 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 9.8 • n=5 Participants	57.3 years STANDARD_DEVIATION 10.0 • n=7 Participants	57.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	72 Participants n=7 Participants	136 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	71 Participants n=7 Participants	146 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	103 Participants n=5 Participants	110 Participants n=7 Participants	213 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants	120 Participants n=7 Participants	229 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Germany	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Mexico	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Region of Enrollment Romania	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	33 Participants n=7 Participants	69 Participants n=5 Participants
Percentage of Hemoglobin A1c (HbA1c) at Baseline	7.82 Percentage of HbA1c STANDARD_DEVIATION 0.69 • n=5 Participants	7.82 Percentage of HbA1c STANDARD_DEVIATION 0.73 • n=7 Participants	7.82 Percentage of HbA1c STANDARD_DEVIATION 0.71 • n=5 Participants

PRIMARY 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 for this outcome, excluding participants discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=114 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=105 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Change From Baseline in HbA1c	-1.59 percentage of HbA1c Standard Error 0.073	-0.69 percentage of HbA1c Standard Error 0.074

SECONDARY outcome

Timeframe: Baseline, Week 40

LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=123 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=111 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Change From Baseline in Body Weight	-11.0 kilograms (kg) Standard Error 0.48	-3.6 kilograms (kg) Standard Error 0.49

SECONDARY outcome

Timeframe: Week 40

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Missing endpoint measures are imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for Baseline HbA1c Value, Baseline SGLT2i use(Yes/No), Treatment, Visit, and Treatment by Visit interaction.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=114 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=105 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieved HbA1c <7%	84.21 percentage of participants	52.38 percentage of participants

SECONDARY outcome

Timeframe: Week 40

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=134 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=132 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieved HbA1c <=6.5%	73.88 percentage of participants	22.73 percentage of participants

SECONDARY outcome

Timeframe: Week 40

The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable. Logistic regression model was used with missing endpoint measures imputed by predictions from an MMRM analysis model using observed data in the efficacy analysis set and adjusted for baseline HbA1c, geographic region 1, number of background OAMs in group 1, dulaglutide dose at screening, and treatment as factors.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=134 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=132 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieved HbA1c <5.7%	21.64 percentage of participants	2.27 percentage of participants

SECONDARY outcome

Timeframe: Week 40

Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HBA1C Group + Treatment + Time + Treatment\*Time.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=134 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=131 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥5%	84.33 percentage of participants	37.40 percentage of participants

SECONDARY outcome

Timeframe: Week 40

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=134 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=131 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥10%	58.21 percentage of participants	6.87 percentage of participants

SECONDARY outcome

Timeframe: Week 40

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=134 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=131 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieve Weight Loss From Baseline of ≥15%	27.61 percentage of participants	0.76 percentage of participants

SECONDARY outcome

Timeframe: Week 40

A composite endpoint is defined as HbA1c ≤ 6.5%, weight loss ≥ 10%, and no hypoglycemia, defined as blood glucose (BG) \<3.0 millimole/liter (mmol/L) and/or severe hypoglycemia. Missing endpoint measures are imputed by predictions using observed data in the efficacy analysis set from the same treatment group through an MMRM analysis model for post-baseline measures: For HbA1c: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Treatment + Time + Treatment\*Time. For Weight: Variable = Baseline + Geographic Region 1 + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Baseline HbA1c Group + Treatment + Time + Treatment\*Time.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=133 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=131 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Percentage of Participants Who Achieved Composite Endpoint (HbA1c <=6.5% & Weight Loss >=10% & No-Hypoglycemia)	46.62 percentage of participants	4.58 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 40

LSMean was calculated using the ANCOVA model for endpoint measures: Variable = Baseline + A1CGR1 + DULDSCRN + OAMGR1 + REGION1 + Treatment (Type I sum of squares).

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=123 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=128 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Change From Baseline in Fasting Serum Glucose (FSG)	-2.00 millimole per liter (mmol/L) Standard Error 0.149	-1.10 millimole per liter (mmol/L) Standard Error 0.150

SECONDARY outcome

Timeframe: Baseline, Week 40

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=123 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=111 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Change From Baseline in Waist Circumference	-8.2 centimeter (cm) Standard Error 0.94	-3.1 centimeter (cm) Standard Error 0.97

SECONDARY outcome

Timeframe: Baseline, Week 40

Change from Baseline in BMI is presented. LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Number of Background OAMs Group 1 + Dulaglutide Dose at Screening + Geographic Region 1 + Baseline HbA1c Group + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=123 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=111 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Change From Baseline in Body Mass Index (BMI)	-3.9 Kilogram per square meter (kg/m^2) Standard Error 0.17	-1.3 Kilogram per square meter (kg/m^2) Standard Error 0.18

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 for this outcome, excluding patients discontinuing study drug due to inadvertent enrollment and data after initiating rescue antihyperglycemic medication or prematurely stopping study drug.

The IWQOL-Lite-CT is a 20-item, obesity-specific PRO (patient-reported outcome) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial (13 items). The IWQOL-Lite-CT provides composite scores for each domain, as well as a total score, all ranging from 0 to 100. Higher scores reflect better levels of functioning. This endpoint shows results for 'physical function domain.'

Outcome measures

Outcome measures
Measure	15 mg Tirzepatide or MTD n=121 Participants Participants received tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=104 Participants Participants received dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was either 1.5 mg QW, which increased by 1.5 mg every 4 weeks (1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached, or 3.0 mg QW, which increased to 4.5 mg after 4 weeks or until MTD was reached.
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) - Physical Functioning Score	11.8 score on a scale Standard Error 1.77	7.8 score on a scale Standard Error 1.91

Adverse Events

15 mg Tirzepatide or MTD

Serious events: 10 serious events

Other events: 77 other events

Deaths: 1 deaths

4.5 mg Dulaglutide or MTD

Serious events: 10 serious events

Other events: 79 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08004595979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	15 mg Tirzepatide or MTD n=139 participants at risk Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until 15 mg or MTD was reached.	4.5 mg Dulaglutide or MTD n=143 participants at risk Participants received 4.5 mg of dulaglutide administered as SC injection via a SDP QW for 40 weeks. The starting dose of dulaglutide was 0.75 mg QW, which increased by 1.5 mg every 4 weeks (0.75 mg to 1.5 mg to 3 mg to 4.5 mg) until 4.5 mg or MTD was reached.
Gastrointestinal disorders Abdominal distension	5.0% 7/139 • Number of events 8 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 3/143 • Number of events 5 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Constipation	8.6% 12/139 • Number of events 18 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	7.7% 11/143 • Number of events 17 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	22.3% 31/139 • Number of events 96 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	13.3% 19/143 • Number of events 35 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	7.9% 11/139 • Number of events 26 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.1% 3/143 • Number of events 3 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.4% 2/139 • Number of events 2 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 8/143 • Number of events 9 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Nausea	25.2% 35/139 • Number of events 116 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	18.9% 27/143 • Number of events 62 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Vomiting	6.5% 9/139 • Number of events 17 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.8% 14/143 • Number of events 34 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Fatigue	5.8% 8/139 • Number of events 13 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 4/143 • Number of events 6 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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	5.0% 7/139 • Number of events 7 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	3.5% 5/143 • Number of events 5 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Influenza	4.3% 6/139 • Number of events 6 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	9.8% 14/143 • Number of events 15 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Nasopharyngitis	10.1% 14/139 • Number of events 15 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	8.4% 12/143 • Number of events 17 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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	8.6% 12/139 • Number of events 14 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.9% 7/143 • Number of events 7 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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	3.6% 5/139 • Number of events 5 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	5.6% 8/143 • Number of events 10 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. 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	5.0% 7/139 • Number of events 12 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	2.8% 4/143 • Number of events 4 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Headache	5.8% 8/139 • Number of events 12 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	4.2% 6/143 • Number of events 7 • Baseline up to week 44 All randomized participants who received at least one dose of study drug regardless of adherence to study drug or initiation of rescue medication. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.