Phase 3 · Dulaglutide

SURPASS J-mono trial results

A Phase 3 Study of Tirzepatide Monotherapy Compared to Dulaglutide 0.75 mg in Patients With Type 2 Diabetes Mellitus

Change From Baseline in Hemoglobin A1c (HbA1c) (percentage of HbA1c), Baseline, Week 52. 5 mg Tirzepatide: -2.37; 10 mg Tirzepatide: -2.55; 15 mg Tirzepatide: -2.82; 0.75 mg Dulaglutide: -1.29.

Participants: 636
Status: completed
Completed: 2021-03-31
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT03861052), updated at source Apr 14, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SURPASS J-mono measured first

Change From Baseline in Hemoglobin A1c (HbA1c)percentage of HbA1c · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=158	10 mg Tirzepatiden=156	15 mg Tirzepatiden=159	0.75 mg Dulaglutiden=159
-2.37(0.066)	-2.55(0.067)	-2.82(0.066)	-1.29(0.065)

Side effects by arm

Side effects in SURPASS J-mono

Percent of participants affected, Baseline through Week 52. The most common events the registry lists.

Event	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide	0.75 mg Dulaglutide
Any serious event	5%	6.3%	4.4%	8.8%
Decreased appetite	13.8%	13.3%	21.9%	4.4%
Nausea	11.9%	19.6%	20%	7.5%
Nasopharyngitis	18.2%	15.8%	13.8%	16.4%
Constipation	15.1%	17.7%	13.8%	10.7%
Diarrhoea	17%	8.9%	11.3%	6.9%
Vomiting	8.2%	5.1%	11.9%	1.3%
Abdominal discomfort	6.3%	7%	10%	2.5%
Injection site reaction	1.3%	3.2%	5.6%	7.5%
Lipase increased	7.5%	4.4%	6.3%	3.1%
Dyspepsia	5.7%	5.1%	6.3%	1.3%
Gastroenteritis	5.7%	1.3%	4.4%	2.5%
Hyperglycaemia	0.6%	0%	0.6%	5.7%
Back pain	5%	3.2%	5.6%	4.4%
Headache	5%	5.1%	1.3%	3.8%
Amylase increased	5%	1.9%	3.1%	0.6%
Abdominal distension	3.8%	2.5%	4.4%	1.3%
Abdominal pain	2.5%	1.3%	4.4%	1.9%
Gastrooesophageal reflux disease	0.6%	1.3%	4.4%	1.9%
Cystitis	4.4%	0.6%	0%	1.3%
Pharyngitis	1.9%	4.4%	3.8%	4.4%
Dizziness	1.3%	2.5%	4.4%	1.3%
Malaise	1.9%	3.8%	1.9%	1.9%
Gallbladder polyp	0.6%	0%	3.8%	0%
Ovarian cyst	0%	0%	3.6%	0%
Pruritus	0.6%	3.2%	1.3%	1.3%

Secondary outcomes

What else it measured

Percentage of Participants With HbA1c of <7.0%percentage of participants · Week 52 · number

5 mg Tirzepatiden=158	10 mg Tirzepatiden=156	15 mg Tirzepatiden=159	0.75 mg Dulaglutiden=159
93.67	96.79	99.37	67.30

Change From Baseline in Fasting Serum Glucosemilligrams per decilitre (mg/dL) · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=158	10 mg Tirzepatiden=156	15 mg Tirzepatiden=159	0.75 mg Dulaglutiden=159
-57.9(1.73)	-64.6(1.76)	-67.6(1.75)	-31.9(1.73)

Change From Baseline in Average 7-Point Self-Monitored Blood Glucose (SMBG) Valuesmg/dL · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=141	10 mg Tirzepatiden=133	15 mg Tirzepatiden=135	0.75 mg Dulaglutiden=137
-59.5(1.46)	-64.2(1.50)	-68.6(1.50)	-42.2(1.48)

Change From Baseline in Body Weightkilogram (kg) · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=158	10 mg Tirzepatiden=156	15 mg Tirzepatiden=159	0.75 mg Dulaglutiden=159
-5.8(0.41)	-8.5(0.42)	-10.7(0.41)	-0.5(0.41)

Percentage of Participants Who Achieve Weight Loss ≥5% From Baselinepercentage of participants · Week 52 · number

5 mg Tirzepatiden=158	10 mg Tirzepatiden=156	15 mg Tirzepatiden=159	0.75 mg Dulaglutiden=159
60.76	82.05	89.31	10.69

Change From Baseline in Fasting Insulinmilliunits per litre (mU/L) · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=148	10 mg Tirzepatiden=146	15 mg Tirzepatiden=157	0.75 mg Dulaglutiden=155
-1.07(0.374)	-1.87(0.344)	-2.00(0.335)	1.40(0.482)

Change From Baseline in Fasting C-Peptidemicrograms per liter (ug/L) · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=148	10 mg Tirzepatiden=146	15 mg Tirzepatiden=157	0.75 mg Dulaglutiden=155
-0.25(0.045)	-0.39(0.042)	-0.37(0.042)	0.01(0.052)

Change From Baseline in Homeostasis Model Assessment B (HOMA-2B, Insulin)percentage of insulin sensitivity · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=146	10 mg Tirzepatiden=137	15 mg Tirzepatiden=147	0.75 mg Dulaglutiden=153
38.5(2.15)	43.0(2.38)	46.3(2.44)	22.4(1.66)

Change From Baseline in HOMA-2S (Insluin)percentage of insulin sensitivity · Baseline, Week 52 · least squares mean

5 mg Tirzepatiden=146	10 mg Tirzepatiden=137	15 mg Tirzepatiden=147	0.75 mg Dulaglutiden=153
14.5(3.38)	21.6(3.83)	25.7(3.95)	-5.4(2.52)

Rate of Hypoglycemia With Glucose < 54 mg/dL or Severe HypoglycemiaEpisodes/participant/365.25 days · Baseline through Week 52 · number

5 mg Tirzepatiden=159	10 mg Tirzepatiden=158	15 mg Tirzepatiden=160	0.75 mg Dulaglutiden=159
0	0	0.012	0

Number of Participants With Anti-Tirzepatide Antibodiesparticipants · Baseline through Week 52 · number

5 mg Tirzepatiden=158	10 mg Tirzepatiden=158	15 mg Tirzepatiden=160	0.75 mg Dulaglutiden=159
97	102	123	8

The trial

How SURPASS J-mono was run

The reason for this study is to see if the study drug tirzepatide (LY3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in Japan.

5 mg Tirzepatide: Participants received 5 milligram (mg) tirzepatide administered subcutaneously (SC) once weekly for 52 weeks.
10 mg Tirzepatide: Participants received 10 mg tirzepatide administered SC once weekly for 52 weeks.
15 mg Tirzepatide: Participants received 15 mg tirzepatide administered SC once weekly for 52 weeks.
0.75 mg Dulaglutide: Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks.

Who could join the trial

Inclusion Criteria: Participant must: * Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit. * Have HbA1c meeting the following criteria, as determined by the central laboratory at screening and baseline: * for participants who are oral antihyperglycemic medication (OAM)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline. * for participants who have been taking OAM monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline. * Have body mass index (BMI) of ≥23 kilograms per meter squared at screening. * Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment. Exclusion Criteria: Participant must not: * Have type 1 diabetes mellitus. * Have had chronic or acute pancreatitis any time prior to study entry. * Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment. * Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. * Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range. * Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. * Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. * Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Published papers

Papers from SURPASS J-mono

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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