Adults 20 to 70, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationPrimary· Baseline through Day 85
Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Group
Value
95% CI
Placebo
0
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
0
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
0
5 mg Tirzepatide (Cohort 3)
0
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of TirzepatideSecondary· Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma.
Day 1
Group
Value
95% CI
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
215
± 18
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
442
± 23
5 mg Tirzepatide (Cohort 3)
364
± 20
Day 50
Group
Value
95% CI
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
1520
± 15
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
2270
± 17
5 mg Tirzepatide (Cohort 3)
838
± 22
PK: Area Under the Concentration Versus Time Curve (AUC) of TirzepatideSecondary· Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration
Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\[0- τ\]), where tau is dosing interval of (0-168 hours).
Day 1
Group
Value
95% CI
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
26100
± 27
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
54400
± 16
5 mg Tirzepatide (Cohort 3)
48800
± 16
Day 50
Group
Value
95% CI
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
192000
± 16
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
285000
± 15
5 mg Tirzepatide (Cohort 3)
104000
± 19
Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma GlucoseSecondary· Baseline, Week 8
Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM
Group
Value
95% CI
Placebo
-4.0
± 23.7
2.5 mg/5 mg/10 mg Tirzepatide (Cohort 1)
-77.5
± 24.2
5 mg/10 mg/15 mg Tirzepatide (Cohort 2)
-72.6
± 30.9
5 mg Tirzepatide (Cohort 3)
-51.7
± 28.9
Adverse events — posted to ClinicalTrials.gov
Time frame: Up To 85 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purposes of this study are to determine:
* The safety of tirzepatide and any side effects that might be associated with it.
* How much tirzepatide gets into the bloodstream and how long it takes the body to remove it.
* How tirzepatide affects the levels of blood sugar.
This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07468552 — Trial of Tirzepatide for the Treatment of Cannabis Use Disorder
· Phase 2
· not yet recruiting
NCT06732245 — Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese
· Phase 2
· not yet recruiting
NCT07349641 — A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia
· Phase 2
· not yet recruiting
NCT07265752 — Tirzepatide for the Treatment of Cannabis Use Disorder
· Phase 2
· not yet recruiting
NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
· NA
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 23 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03322631.