A Phase 2 interventional study of Tirzepatide and Placebo in Type 2 Diabetes and Obesity, sponsored by Eli Lilly and Company. Active, not recruiting at 40 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.
The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 414 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive tirzepatide subcutaneously (SC).
Drug: Tirzepatide
Participants will receive tirzepatide SC.
Drug: Tirzepatide
Participants will receive tirzepatide SC.
Drug: Tirzepatide
Participants will receive placebo.
Drug: Placebo
Administered SC
Also known as: LY3298176
Administered SC
Percent Change From Baseline in Body Weight
Time frame: Baseline (Week 0), Week 44
Change from Baseline in HbA1c
Time frame: Baseline (Week 0), Week 44
Change from Baseline in HbA1c
Time frame: Baseline (Week 24), Week 80
Percent Change from Baseline in Body Weight
Time frame: Baseline (Week 24), Week 80
Absolute Change from Baseline in Body Weight
Time frame: Baseline (Week 0), Week 44
Absolute Change from Baseline in Body Weight
Time frame: Baseline (Week 24), Week 80
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline (Week 0), Week 44
Change from Baseline in BMI
Time frame: Baseline (Week 24), Week 80
Change from Baseline in Waist Circumference
Time frame: Baseline (Week 0), Week 44
Change from Baseline in Waist Circumference
Time frame: Baseline (Week 24), Week 80
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time frame: Baseline (Week 0), Week 44
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time frame: Baseline (Week 0), Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.
Time frame: Baseline through Week 44
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: ata are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tirzepatide