Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05963022 | A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO) | PHASE3 | COMPLETED | 206 | — | — | Aug 21, 2023 | Oct 9, 2024 | Oct 21, 2025 | 28 | China |
| NCT04657003 | A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight | PHASE3 | COMPLETED | 938 | — | — | Mar 29, 2021 | Apr 10, 2023 | Apr 8, 2024 | 75 | United States, Argentina +6 |
| NCT04537923 | A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin | PHASE3 | COMPLETED | 1,428 | — | — | Oct 19, 2020 | Nov 1, 2022 | Nov 2, 2023 | 135 | United States, Argentina +14 |
| NCT04093752 | A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo) | PHASE3 | COMPLETED | 917 | — | — | Dec 9, 2019 | Nov 24, 2021 | Jan 6, 2023 | 67 | Australia, China +2 |
| NCT04039503 | A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin | PHASE3 | COMPLETED | 475 | — | — | Aug 30, 2019 | Jan 13, 2021 | Jan 12, 2022 | 48 | United States, Czechia +6 |
| NCT03987919 | A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes | PHASE3 | COMPLETED | 1,879 | — | — | Jul 30, 2019 | Feb 15, 2021 | Feb 14, 2022 | 127 | United States, Argentina +7 |
| NCT03861052 | A Study of Tirzepatide (LY3298176) Compared to Dulaglutide in Participants With Type 2 Diabetes | PHASE3 | COMPLETED | 636 | — | — | May 7, 2019 | Mar 31, 2021 | Apr 14, 2022 | 46 | Japan |
| NCT06037252 | A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity | PHASE2 | ACTIVE NOT_RECRUITING | 414 | — | — | Sep 21, 2023 | Oct 1, 2026 | Mar 23, 2026 | 40 | United States, Argentina +2 |
| NCT03311724 | A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes | PHASE2 | COMPLETED | 111 | — | — | Oct 19, 2017 | Apr 24, 2018 | May 19, 2021 | 13 | United States |
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 calculated using ANCOVA model with Baseline + Prior Antihyperglycemic Use + Treatment (Type III sum of squares) as variables.
Least Squares Mean (LSMean) calculated using Mixed Model Repeated Measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Type of Antihyperglycemic Medication (AHM) Used at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of participants who achieve ≥5% body weight reduction from baseline
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 with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
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 with covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment\*Time (Type III sum of squares).
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 with Baseline + Baseline Metformin Use (Yes, No) + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Least squares (LS) mean was calculated using mixed model repeated measures model (MMRM) with baseline + baseline BMI group + baseline metformin flag + treatment + time + treatment\*time as fixed factors.
| Arm | Type | Description |
|---|---|---|
| 5 Milligram (mg) Tirzepatide | EXPERIMENTAL | Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached. |
| 10 mg Tirzepatide | EXPERIMENTAL | Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached. |
| 15 mg Tirzepatide | EXPERIMENTAL | Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached. |
| Placebo | PLACEBO_COMPARATOR | Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks. |
| 10 milligrams (mg) Tirzepatide | EXPERIMENTAL | 10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW) |
| 5 mg Tirzepatide | EXPERIMENTAL | 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week. |
| Insulin Lispro | ACTIVE_COMPARATOR | Insulin lispro 100 units per milliliter (U100) administered SC three times a day. |
| Insulin Glargine | ACTIVE_COMPARATOR | Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm. |
| 1 mg Semaglutide | ACTIVE_COMPARATOR | 1 mg semaglutide administered SC once a week. |
| 0.75 mg Dulaglutide | ACTIVE_COMPARATOR | Participants received 0.75 mg dulaglutide administered SC once weekly for 52 weeks. |
| Tirzepatide High Dose 1 | EXPERIMENTAL | Participants will receive tirzepatide subcutaneously (SC). |
| Tirzepatide High Dose 2 | EXPERIMENTAL | Participants will receive tirzepatide SC. |
| Tirzepatide | ACTIVE_COMPARATOR | Participants will receive tirzepatide SC. |
| 4,8,12mg Tirzepatide | EXPERIMENTAL | Participants received Tirzepatide by subcutaneous (SC) injection in three dose escalations starting with 4 milligrams (mg) for four weeks followed by 8mg for four weeks followed by 12mg for four weeks. |
| 2.5,5,10,15mg Tirzepatide | EXPERIMENTAL | Participants received Tirzepatide by SC injection in four dose escalations starting with 2.5mg for two weeks followed by 5mg for two weeks followed by 10mg for four weeks followed by 15mg for four weeks. |
| 2.5,7.5,15mg Tirzepatide | EXPERIMENTAL | Participants received Tirzepatide by SC injection in three dose escalations starting with 2.5mg for four weeks followed by 7.5mg for four weeks followed by 15mg for four weeks. |
| Name | Type | Description |
|---|---|---|
| Tirzepatide | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
| Insulin Lispro (U100) | DRUG | Administered SC |
| Insulin Glargine | DRUG | Administered SC |
| Semaglutide | DRUG | Administered SC |
| Dulaglutide | DRUG | Administered SC |
Inclusion Criteria: * Have Type 2 Diabetes * Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment * Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of red...