20 and older, 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 Week 52
An SAE is any AE from this study that results in one of the following outcomes:
* Death
* Initial or prolonged inpatient hospitalization
* A life-threatening experience (that is, immediate risk of dying)
* Persistent or significant disability/incapacity
* Congenital anomaly/birth defect.
* Important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require.
A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Group
Value
95% CI
5 mg Tirzepatide
0
10 mg Tirzepatide
1
15 mg Tirzepatide
1
Change From Baseline in Hemoglobin A1c (HbA1c)Secondary· Baseline, Week 52
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + oral antihyperglycemic medication (OAM) Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Group
Value
95% CI
5 mg Tirzepatide
-2.57
± 0.075
10 mg Tirzepatide
-2.98
± 0.075
15 mg Tirzepatide
-3.02
± 0.077
Percentage of Participants Who Achieve HbA1c <7%Secondary· Week 52
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Group
Value
95% CI
5 mg Tirzepatide
92.57
10 mg Tirzepatide
97.95
15 mg Tirzepatide
96.55
Change From Baseline in Fasting Serum GlucoseSecondary· Baseline, Week 52
Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Group
Value
95% CI
5 mg Tirzepatide
-58.6
± 1.75
10 mg Tirzepatide
-71.2
± 1.75
15 mg Tirzepatide
-74.4
± 1.81
Mean Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) ValuesSecondary· Baseline, Week 52
The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Postmeal, Midday Premeal, Midday 2-hour Postmeal, Evening Premeal, Evening 2-hour Postmeal and Bedtime. LS mean was determined by analysis of covariance (ANCOVA) model for endpoint measures: Variable = Baseline + OAM Group 1 + Treatment (Type III sum of squares).
Group
Value
95% CI
5 mg Tirzepatide
-80.0
± 1.91
10 mg Tirzepatide
-94.1
± 1.92
15 mg Tirzepatide
-96.3
± 1.99
Change From Baseline in Body WeightSecondary· Baseline, Week 52
LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Group
Value
95% CI
5 mg Tirzepatide
-3.8
± 0.51
10 mg Tirzepatide
-7.5
± 0.51
15 mg Tirzepatide
-10.2
± 0.52
Percentage of Participants Who Achieve Weight Loss of ≥5% From BaselineSecondary· Week 52
Percentage of Participants who Achieve Weight Loss of ≥5% from Baseline
Group
Value
95% CI
5 mg Tirzepatide
43.92
10 mg Tirzepatide
70.55
15 mg Tirzepatide
84.14
Change From Baseline in Fasting InsulinSecondary· Baseline, Week 52
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Group
Value
95% CI
5 mg Tirzepatide
6.2
± 2.68
10 mg Tirzepatide
-4.8
± 2.21
15 mg Tirzepatide
-7.7
± 2.16
Change From Baseline in Fasting C-PeptideSecondary· Baseline, Week 52
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares).
Group
Value
95% CI
5 mg Tirzepatide
-0.12
± 0.044
10 mg Tirzepatide
-0.28
± 0.040
15 mg Tirzepatide
-0.34
± 0.040
Change From Baseline in Homeostasis Model Assessment B (HOMA-2B) (Insulin)Secondary· Baseline, Week 52
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treat
Group
Value
95% CI
5 mg Tirzepatide
39.7
± 2.16
10 mg Tirzepatide
44.9
± 2.40
15 mg Tirzepatide
49.2
± 2.60
Change From Baseline in HOMA-2S (Insulin)Secondary· Baseline, Week 52
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).
LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement) = log(Baseline) + OAM Group 1 + Treatment + Time + Treat
Group
Value
95% CI
5 mg Tirzepatide
-0.1
± 3.37
10 mg Tirzepatide
16.7
± 4.23
15 mg Tirzepatide
24.1
± 4.66
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 TherapySecondary· Baseline through Week 56
The hypoglycemia events were defined by participant reported events with blood glucose \<54mg/dL (\<3.0 mmol/L) or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Group
Value
95% CI
5 mg Tirzepatide
1
10 mg Tirzepatide
1
15 mg Tirzepatide
3
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline through Week 56.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
5 mg Tirzepatide
Serious: 2/148 (1%)
Deaths: 0/148
10 mg Tirzepatide
Serious: 11/147 (7%)
Deaths: 0/147
15 mg Tirzepatide
Serious: 11/148 (7%)
Deaths: 0/148
Serious adverse events (25 terms)
Reaction
System
5 mg Tirzepatide
10 mg Tirzepatide
15 mg Tirzepatide
Cataract
Eye disorders
—
—
—
Angina pectoris
Cardiac disorders
—
—
—
Atrioventricular block complete
Cardiac disorders
—
—
—
Vertigo positional
Ear and labyrinth disorders
—
—
—
Eyelid ptosis
Eye disorders
—
—
—
Macular fibrosis
Eye disorders
—
—
—
Colitis ulcerative
Gastrointestinal disorders
—
—
—
Cholelithiasis
Hepatobiliary disorders
—
—
—
Appendicitis
Infections and infestations
—
—
—
Diabetic gangrene
Infections and infestations
—
—
—
Pneumonia legionella
Infections and infestations
—
—
—
Clavicle fracture
Injury, poisoning and procedural complications
—
—
—
Radius fracture
Injury, poisoning and procedural complications
—
—
—
Joint contracture
Musculoskeletal and connective tissue disorders
—
—
—
Spinal ligament ossification
Musculoskeletal and connective tissue disorders
—
—
—
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Bladder papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Renal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Facial paralysis
Nervous system disorders
—
—
—
Nephrolithiasis
Renal and urinary disorders
—
—
—
Ureterolithiasis
Renal and urinary disorders
—
—
—
Coronary artery bypass
Surgical and medical procedures
—
—
—
Intra-cerebral aneurysm operation
Surgical and medical procedures
—
—
—
Other adverse events (266 terms — click to expand)
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
Publications & conference data
8 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
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes
· Phase 3
· recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus
· recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With
· Phase 1
· recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes
· NA
· active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic
· recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
· Phase 2
· not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
· Phase 2
· not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants
· Phase 1
· completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants
· Phase 1
· completed
NCT07030127 — A Study of LY3985863 in Healthy Participants
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 14 February 2022
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/NCT03861039.