Diabetes Mellitus, Type 2Phase 1NCT04235959

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

A Phase 1 study testing Tirzepatide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to learn more about the safety and side effects of tirzepatide in Chinese participants with type 2 diabetes mellitus. The study will also measure how much tirzepatide gets into the bloodstream and how long it takes the body to remove it. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Tirzepatide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 2 sitesChina
Study dates: 21 Oct 2020to 17 Aug 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

Peking University First Hospital
Beijing, 100034
West China Hospital Sichuan University
Chengdu, Sichuan, 610041

Other trials in China

About this study

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

Conditions: Diabetes Mellitus, Type 2
Being tested: Tirzepatide, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC

Study groups in NCT04235959
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo once weekly (QW) subcutaneously (SC). Receives: Drug: Placebo
Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)	Experimental	Participants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15. Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23. Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.
The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
Measured: Baseline up to 43 Weeks

Secondary outcomes (4)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1)
PK: AUC [0-168] of Tirzepatide.
Measured: 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).
PK: AUC [0-168] of Tirzepatide (Cohort 2)
PK: AUC [0-168] of Tirzepatide.
Measured: 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).
PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1)
PK: Cmax of Tirzepatide.
Measured: 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).
PK: Cmax of Tirzepatide (Cohort 2)
PK: Cmax of Tirzepatide.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202017 Aug 2021

First posted22 Jan 2020
Study start21 Oct 2020
Primary completion17 Aug 2021
Study completion17 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04235959
Sponsor's protocol ID: 17379
Other IDs: I8F-MC-GPHT
Status last verified: Aug 2022
First submitted: 20 Jan 2020
Last updated: 6 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Feng P, Sheng X, Ji Y, Urva S, Wang F, Miller S, Qian C, An Z, Cui Y. A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes. Adv Ther. 2023 Aug;40(8):3434-3445. doi: 10.1007/s12325-023-02536-8. Epub 2023 Jun 7.
PubMed 37285081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Titration Study in Chinese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Tirzepatide
ClinicalTrials.gov ID: NCT04235959
Acronym / sponsor ID: 17379
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 21 Oct 2020 (actual)
Primary completion: 17 Aug 2021 (actual)
Study completion: 17 Aug 2021 (actual)
First posted: 22 Jan 2020 (actual)
Results: Posted 6 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo once weekly (QW) subcutaneously (SC).
Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)	Experimental	Drug: TirzepatideParticipants in Cohort 1 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15. Participants in Cohort 2 received weekly SC doses of tirzepatide with titration regimen starting from 2.5 mg for Weeks 0 through 3 followed by 5 mg for Weeks 4 through 7, 7.5 mg for Weeks 8 through 11, and 10 mg for Weeks 12 through 15, 12.5 mg for Weeks 16 through 19, and 15 mg for Weeks 20 through 23.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TirzepatideAlso: LY3298176Administered SC	Drug	Tirzepatide - Cohort 1 (2.5 to 10 Milligram (mg)) and Cohort 2 (2.5 to 15 mg)
PlaceboAdministered SC	Drug	Placebo

Primary outcome

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
The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.

4 secondary outcomes

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).
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).
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).
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).

Results and safety

Results posted to the registry on 6 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	4	3
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)	10	9
Cohort 2 (2.5 to 15 mg Tirzepatide)	10	10

Primary outcome: 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. Number. Unit: participants

Measure	Placebo n = 4	Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide) n = 10	Cohort 2 (2.5 to 15 mg Tirzepatide) n = 10
Value	1	0	0

Population analysed: All participants who received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 43 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 4 (25%)	4 of 4 (100%)	0 of 4
Cohort 1 (2.5 to 10 Milligram (mg) Tirzepatide)	0 of 10 (0%)	10 of 10 (100%)	0 of 10
Cohort 2 (2.5 to 15 mg Tirzepatide)	0 of 10 (0%)	10 of 10 (100%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37285081Feng P, Sheng X, Ji Y, Urva S, Wang F, Miller S, Qian C, An Z, Cui Y. A Phase 1 Multiple Dose Study of Tirzepatide in Chinese Patients with Type 2 Diabetes. Adv Ther. 2023 Aug;40(8):3434-3445. doi: 10.1007/s12325-023-02536-8. Epub 2023 Jun 7.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tirzepatide in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.