CompletedPhase 1Results posted

A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus

A Multiple Dose Titration Study in Chinese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Tirzepatide

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

Primary endpoint

•Serious AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04235959

Org study ID17379

Secondary IDI8F-MC-GPHTEli Lilly and Company

Timeline

Milestones

Study first posted2020-01-22actual

Study start2020-10-21actual

Primary completion2021-08-17actual

Study completion2021-08-17actual

Last update posted2023-07-06actual

Results first posted2023-07-06actual

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are stable on a single oral antihyperglycemic medication (OAM), metformin, acarbose, or sulphonylureas only (other types of OAM [dipeptidyl peptidase IV inhibitors, sodium-glucose cotransporter-2 inhibitors, and thiazolidinediones] are not allowed in this study), for at least 3 months

•Have a body mass greater than or equal to (≥)23 kilograms per square meter (kg/m²), inclusive

Exclusion criteria

•Have type 1 diabetes mellitus

•Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Visit 1

•Have a history of heart block or PR interval greater than (>)220 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study

•Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or a GI disease that impacts gastric emptying or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

•Have known allergies to tirzepatide, GLP-1 analogs, or related compounds or any components of the formulation

Endpoints (10)

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.

Safety / tolerability / PK

10 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 up to 43 Weeks

Serious AEs (any)

event count, event

Posted result

Group	Number · participants	95% CI
Placebo	1	-
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)	0	-
Cohort 2 (2.5 to 15 mg Tirzepatide)	0	-

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 up to 43 Weeks

Serious AEs (any)

event count, event

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

concentration, descriptive

Posted result

Group	Geometric mean · nanogram hour per milliliter (ng*h/mL)	95% CI
Cohort 1: 2.5 to 10 mg TirzepatideWeek 0	35100	-
Week 7	125000	-
Week 15	263000	-

Secondary/registry result

PK: AUC [0-168] of Tirzepatide (Cohort 2)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

concentration, descriptive

Posted result

Group	Geometric mean · nanogram hour per milliliter (ng*h/mL)	95% CI
Cohort 2: 2.5 to 15 mg TirzepatideWeek 0	30900	-
Week 7	110000	-
Week 23	357000	-

Secondary/registry result

PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms per milliliter (ng/mL)	95% CI
Cohort 1: 2.5 to 10 mg TirzepatideWeek 0	306	-
Week 7	1030	-
Week 15	2200	-

Secondary/registry result

PK: Cmax of Tirzepatide (Cohort 2)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms per milliliter (ng/mL)	95% CI
Cohort 2: 2.5 to 15 mg TirzepatideWeek 0	257	-
Week 7	915	-
Week 23	2930	-

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

PK: AUC [0-168] of Tirzepatide (Cohort 2)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK: Cmax of Tirzepatide (Cohort 2)

Time frame:Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).

Cmax

concentration, descriptive

Publications (1)

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

A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes.
Advances in therapy2023 Aug (month)PMID37285081doi:10.1007/s12325-023-02536-8via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.