GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

443

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7-11%

Primary endpoint

•Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03861039

Org study ID17078

Secondary IDI8F-JE-GPGPEli Lilly and Company

Timeline

Milestones

Study first posted2019-03-04actual

Study start2019-03-30actual

Primary completion2021-01-26actual

Study completion2021-02-16actual

Last update posted2022-02-14actual

Results first posted2022-02-14actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

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 ≥7.0% to <11.0%, as determined by the central laboratory at screening.

•Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening.

•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.

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms (kg)	95% CI
5 mg Tirzepatide	-3.8	—
10 mg Tirzepatide	-7.5	—
15 mg Tirzepatide	-10.2	—

Secondary/registry result

Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	43.92	—
10 mg Tirzepatide	70.55	—
15 mg Tirzepatide	84.14	—

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Loss of ≥5% From Baseline

Time frame:Week 52

≥5% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

16 endpoints

Secondary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
5 mg Tirzepatide	-2.57	—
10 mg Tirzepatide	-2.98	—
15 mg Tirzepatide	-3.02	—

Secondary/registry result

Percentage of Participants Who Achieve HbA1c <7%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	92.57	—
10 mg Tirzepatide	97.95	—
15 mg Tirzepatide	96.55	—

Secondary/registry result

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram per Deciliter (mg/dL)	95% CI
5 mg Tirzepatide	-58.6	—
10 mg Tirzepatide	-71.2	—
15 mg Tirzepatide	-74.4	—

Secondary/registry result

Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
5 mg Tirzepatide	-80.0	—
10 mg Tirzepatide	-94.1	—
15 mg Tirzepatide	-96.3	—

Secondary/registry result/low confidence

Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), picomol per liter (pmol/L)	95% CI
5 mg Tirzepatide	6.2	—
10 mg Tirzepatide	-4.8	—
15 mg Tirzepatide	-7.7	—

Secondary/registry result

Change From Baseline in Fasting C-Peptide

Time frame:Baseline, Week 52

C-peptide AUC

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), micrograms/litre (ug/L)	95% CI
5 mg Tirzepatide	-0.12	—
10 mg Tirzepatide	-0.28	—
15 mg Tirzepatide	-0.34	—

Secondary/registry result

Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)

Time frame:Baseline, Week 52

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of HOMA-2B	95% CI
5 mg Tirzepatide	39.7	—
10 mg Tirzepatide	44.9	—
15 mg Tirzepatide	49.2	—

Secondary/registry result

Change From Baseline in HOMA-2S (Insulin)

Time frame:Baseline, Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage of HOMA-2S	95% CI
5 mg Tirzepatide	-0.1	—
10 mg Tirzepatide	16.7	—
15 mg Tirzepatide	24.1	—

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c <7%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Insulin

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Fasting C-Peptide

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)

Time frame:Baseline, Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in HOMA-2S (Insulin)

Time frame:Baseline, Week 52

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Safety / tolerability / PK

6 endpoints

Primary/registry result

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through Week 52

Serious AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
5 mg Tirzepatide	0	—
10 mg Tirzepatide	1	—
15 mg Tirzepatide	1	—

Primary/protocol endpoint

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through Week 52

Serious AEs (any)

event count, event

Secondary/registry result

Number of Participants With Hypoglycemia Incidence and Rate With Blood Glucose <54 mg/dL or Severe Hypoglycemia, Exclude Hypoglycemic Events Occurring After Initiation of a New Antihyperglycemic Therapy

Time frame:Baseline through Week 56

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (count_of_participants), Participants	95% CI
5 mg Tirzepatide	1	—
10 mg Tirzepatide	1	—
15 mg Tirzepatide	3	—

Secondary/registry result

Number of Participants With Anti-Tirzepatide Antibodies

Time frame:Baseline through Week 52

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
5 mg Tirzepatide	87	—
10 mg Tirzepatide	82	—
15 mg Tirzepatide	88	—

Secondary/protocol endpoint

Time frame:Baseline through Week 56

Severe hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Secondary/protocol endpoint

Number of Participants With Anti-Tirzepatide Antibodies

Time frame:Baseline through Week 52

Immunogenicity (ADA)

threshold achievement, event

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Association Between Early Weight Loss and Metabolic Outcomes with Tirzepatide in Japanese Patients with Type 2 Diabetes: A SURPASS J Post Hoc Analysis.
Diabetes therapy : research, treatment and education of diabetes and related disorders2025 Sep (month)PMID40711720doi:10.1007/s13300-025-01775-yvia clinicaltrials gov reference derived + pubmed nct search
Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial.
The lancet. Diabetes & endocrinology2022 Sep (month)PMID35914542doi:10.1016/S2213-8587(22)00187-5via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.