Product Description
Tirzepatide is a novel investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single molecule, representing a new class of medicines being studied for the treatment of type 2 diabetes. (Sourced from: https://investor.lilly.com/news-releases/news-release-details/tirzepatide-results-published-lancet-show-superior-a1c-and-body)
Mechanisms of Action: GLP-1 Agonist, GIP Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous
FDA Designation: Fast Track - Obesity|Obesity, Morbid|Overweight *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Poland | Portugal | Romania | Saudi Arabia | Slovakia | Spain | Sweden | Switzerland | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Company: Eli Lilly
Company Location: Eastern America
Company Founding Year: 1876
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Eli Lilly presented P3 Obesity results on 2026-05-12 for Tirzepatide
- Clinical Outcomes Reported - Eli Lilly presented P3 Obesity results on 2026-02-18 for Tirzepatide
- Clinical Outcomes Reported - Eli Lilly presented P3 Type 2 Diabetes|Cardiovascular results on 2025-07-30 for Tirzepatide
Highest Development Phases
Phase 3: Apnea|Arthritis, Psoriatic|Bile Duct Cancer|Bladder Cancer|Colitis, Ulcerative|Crohn Disease|Esophageal Cancer|Fatty Liver|Fatty Liver, Alcoholic|Gastrointestinal Cancer|Glucose Metabolism Disorders|Heart Failure, Chronic|Heart Failure, Diastolic|Liver Cancer|Metabolic Dysfunction-Associated Steatohepatitis|Non-alcoholic Fatty Liver Disease|Obesity|Obesity, Morbid|Overweight|Prediabetic State|Psoriasis|Sleep Apnea, Obstructive|Type 1 Diabetes|Type 2 Diabetes|Weight Gain
Phase 2: Binge-Eating Disorder|Breast Cancer|Kidney Diseases|Kidney Failure, Chronic|Overnutrition|Protein Deficiency
Phase 1: General Diabetes|Healthy Volunteers|Pediatric Obesity
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05412004 |
SURMOUNT-OSA | P3 |
Completed |
Sleep Apnea, Obstructive|Obesity |
2024-03-12 |
2025-05-01 |
Primary Endpoints |
|
2024-000081-22 |
A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity | P1 |
Active, not recruiting |
Pediatric Obesity |
2007-09-15 |
2025-07-09 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT07676331 |
CLARA | P2 |
Not yet recruiting |
Breast Cancer |
2028-03-01 |
2026-07-01 |
Primary Endpoints|Treatments |
|
NCT06847399 |
LIBERATE | P2 |
Recruiting |
Obesity|Binge-Eating Disorder|Overweight |
2027-12-01 |
2025-09-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
2023-506082-60-00 |
I8F-MC-GPIG | P2 |
Recruiting |
Obesity|Type 2 Diabetes|Overweight|Kidney Diseases |
2026-12-08 |
50% |
2025-05-02 |
Treatments |
NCT05536804 |
TREASURE-CKD | P2 |
Active, not recruiting |
Kidney Failure, Chronic|Overweight|Obesity|Type 2 Diabetes |
2026-09-01 |
50% |
2025-07-25 |
Primary Endpoints|Treatments|Trial Status |
NCT06965413 |
GYMINDA | P2 |
Active, not recruiting |
Obesity, Morbid|Overweight |
2026-08-24 |
12% |
2026-02-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT06603571 |
W8M-MC-CWMM Master Protocol | P2 |
Active, not recruiting |
Obesity|Overweight|Type 2 Diabetes |
2026-07-01 |
80% |
2026-07-20 |
|
NCT06643728 |
J4Z-MC-GIDF | P2 |
Active, not recruiting |
Protein Deficiency|Overweight|Obesity |
2026-01-16 |
50% |
2026-05-27 |
|
NCT06037252 |
I8F-MC-GPIT | P2 |
Active, not recruiting |
Obesity|Glucose Metabolism Disorders|Type 2 Diabetes|Overnutrition |
2026-01-08 |
50% |
2026-03-24 |
|
ACTRN12626000224325 |
ACTRN12626000224325 | P1 |
Not yet recruiting |
General Diabetes|Healthy Volunteers |
2026-03-18 |
2026-02-24 |
Treatments |
|
jRCT2021250031 |
jRCT2021250031 | P3 |
Not yet recruiting |
Fatty Liver |
2030-10-31 |
|||
NCT07165028 |
SYNERGY-Outcomes | P3 |
Recruiting |
Non-alcoholic Fatty Liver Disease|Fatty Liver, Alcoholic |
2030-08-01 |
62% |
2026-05-15 |
Primary Endpoints|Treatments |
2025-522674-36-00 |
N1T-MC-MALO | P3 |
Not yet recruiting |
Metabolic Dysfunction-Associated Steatohepatitis |
2029-10-11 |
62% |
||
NCT06937099 |
COMMIT-CD | P3 |
Recruiting |
Overweight|Crohn Disease|Obesity |
2028-05-01 |
40% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT06937086 |
COMMIT-UC | P3 |
Recruiting |
Colitis, Ulcerative|Overweight|Obesity |
2028-04-01 |
40% |
2026-04-23 |
Primary Endpoints|Treatments |
NCT06439277 |
SURMOUNT-ADOLESCENTS-2 | P3 |
Recruiting |
Obesity|Weight Gain |
2027-10-01 |
40% |
2025-08-27 |
Primary Endpoints|Treatments |
ACTRN12626000453381 |
INPOWER-GI | P3 |
Not yet recruiting |
Bladder Cancer|Gastrointestinal Cancer|Bile Duct Cancer|Liver Cancer|Esophageal Cancer|Obesity |
2027-05-03 |
|||
NCT06630585 |
AID-JUNCT | P3 |
Recruiting |
Type 1 Diabetes |
2026-06-01 |
2025-06-07 |
||
NCT06588283 |
TOGETHER-PsO | P3 |
Completed |
Psoriasis|Obesity |
2026-01-08 |
27% |
2026-06-18 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06588296 |
TOGETHER-PsA | P3 |
Completed |
Obesity|Arthritis, Psoriatic |
2025-11-18 |
12% |
2026-05-14 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05822830 |
SURMOUNT-5 | P3 |
Completed |
Obesity|Prediabetic State|Overweight |
2024-11-13 |
2025-11-27 |
Primary Endpoints|Treatments |
|
NCT04847557 |
The SUMMIT Trial | P3 |
Completed |
Heart Failure, Chronic|Obesity|Heart Failure, Diastolic |
2024-07-02 |
2024-07-23 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Trial Status |
|
jRCT2031220154 |
jRCT2031220154 | P3 |
Recruiting |
Obesity|Apnea |
2024-05-31 |
|||
NCT05912621 |
Tirzepatide | P2 |
Recruiting |
Overweight|Obesity |
2028-06-01 |
2024-12-05 |
Primary Endpoints |
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