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tirzepatide
FDA-approved since 2022 and marketed in the US as Mounjaro, Zepbound, authorised in the EU as Mounjaro, with no open FDA shortage or discontinuation records. 99 active trials, the next due to complete 2026-11.
GIP/GLP-1 agonist, SC, from Eli Lilly. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.
- Status
- marketed
- Target
- GIP/GLP-1
- Route
- SC
- Sponsor
- Eli Lilly
- First FDA approval
- 2022-05-13
- EU authorisation
- Mounjaro (2022)
- Active trials
- 99 (23 in phase 3)
- Participants enrolled
- 43,878
- Trials with a reporting date
- 35
- Approved FDA submissions
- 27
Approved indications
Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.
ZEPBOUND ® is indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ZEPBOUND is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity: to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. ( 1 ) Limitations of Use: Coadministration with other tirzepatide-containing products or with any GLP-1 receptor agonist is not recommended. ( 1 ) Limitations of Use ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.
MOUNJARO ® is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. MOUNJARO ® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 ) to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. ( 1 )
Recent changes
When these trials report
Next 30 of 35 active trials by estimated primary completion.
| Est. completion | Trial | Sponsor | Phase | Participants |
|---|---|---|---|---|
| 2026-11 | A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity NCT06662383 · Percent Change from Baseline in Body Weight | Eli Lilly and Company | P3 | 800 |
| 2026-11 | A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight NCT06962280 · Change from Baseline in Hemoglobin A1c (HbA1c) | Eli Lilly and Company | P3 | 465 |
| 2026-11 | A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight NCT06914895 · Change from Baseline in Hemoglobin A1c (HbA1c) | Eli Lilly and Company | P3 | 905 |
| 2026-12 | The Long COVID Treatment Trial NCT07128082 · Primary Objective 1: Changes in fatigue severity score, measured by Fatigue Severity Scale (FSS) | Scripps Translational Science Institute | P2 | 1,000 |
| 2026-12-31 | TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation NCT06802081 · AFib burden | The Cleveland Clinic | P2 | 100 |
| 2027-02-04 | Efficacy and Safety of HDM1005 Compared to Tirzepatide in Obese Adults Without Diabetes NCT07521631 · Primary Outcome | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | P2 | 372 |
| 2027-02-14 | Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1) NCT07481747 · Mean percent change in body weight from randomization | Hudson Biotech | P3 | 2,539 |
| 2027-03-20 | The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease NCT06606821 · Lipid core burden index | Tina Vilsbøll | P4 | 124 |
| 2027-05 | Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA) NCT06191848 · Percentage of patients who undergo knee replacement in the target joint | University of Melbourne | P4 | 352 |
| 2027-05-31 | Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide NCT07777575 · Change in contractile thigh muscle volume (mL), as assessed by magnetic resonance imaging (MRI) | Technical University of Munich | P4 | 150 |
| 2027-07 | A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity NCT07438444 · Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration | Eli Lilly and Company | P4 | 344 |
| 2027-07-30 | Tirzepatide in MetALD NCT07046819 · Metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score. | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | P2 | 120 |
| 2027-08 | A Study to Investigate Effectiveness of Tirzepatide Following Initiation of Ixekizumab in Participants With Active Psoriatic Arthritis and Overweight or Obesity in Clinical Practice (TOGETHER AMPLIFY-PsA) NCT06864026 · Percentage of Participants Achieving Normalized Functioning Health Assessment Questionnaire - Disability Index (HAQ-DI) ≤0.5 at 12 Months of Therapy | Eli Lilly and Company | P4 | 200 |
| 2027-08-10 | Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay. NCT07588438 · Mean Percent Change From Baseline in Body Weight at 52 Weeks. | Las Rías Medical Center | P4 | 160 |
| 2027-08-15 | Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese NCT06732245 · Change from baseline in body weight at 48 weeks | Biomed Industries, Inc. | P2 | 224 |
| 2027-09 | A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight NCT06143956 · Number of Participants Allocated to Each ISA | Eli Lilly and Company | P2 | 1,481 |
| 2027-09-28 | A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin NCT07796477 · Change from baseline in Hemoglobin A1c (HbA1c) | CSPC Ouyi Pharmaceutical Co., Ltd. | P2 | 240 |
| 2027-09-30 | Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder NCT06651177 · 6-month retention in BUP treatment | T. John Winhusen, PhD | P2 | 310 |
| 2027-10 | A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity NCT05556512 · Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events) | Eli Lilly and Company | P3 | 15,374 |
| 2027-10 | A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) NCT06439277 · Percent Change from Baseline in Body Mass Index (BMI) | Eli Lilly and Company | P3 | 300 |
| 2027-10-31 | AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes NCT07697391 · Percent Change in Body Weight From Baseline to Week 52 | The First Affiliated Hospital of Anhui Medical University | P4 | 285 |
| 2027-12-01 | Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder NCT06847399 · Percent initial weight loss | Johns Hopkins University | P2 | 105 |
| 2027-12-15 | Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide NCT06657209 · Insulin resistance in normal weight women with diabetes compared to those with no diabetes | Stanford University | P4 | 104 |
| 2028-01 | A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar NCT07284511 · Daytime Time-in-Range | McGill University Health Centre/Research Institute of the McGill University Health Centre | P2/P3 | 105 |
| 2028-03-01 | Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial NCT07676331 · Ki67 proliferation marker | Universitaire Ziekenhuizen KU Leuven | P2 | 168 |
| 2028-03 | Multi-Site Trial of Tirzepatide for Smoking Cessation NCT07602699 · 7-day point prevalence abstinence | University of Southern California | P2 | 300 |
| 2028-03-15 | Trial of Tirzepatide for the Treatment of Cannabis Use Disorder NCT07468552 · Maximum Tolerated Dose (MTD) | National Institute on Drug Abuse (NIDA) | P2 | 100 |
| 2028-04 | Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study NCT06937086 · Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction | Eli Lilly and Company | P3 | 350 |
| 2028-05 | Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight NCT06937099 · Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction | Eli Lilly and Company | P3 | 290 |
| 2028-05 | A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO) NCT06857942 · Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) | Eli Lilly and Company | P4 | 200 |
Regulatory history
| Date | Action | Brands | Application |
|---|---|---|---|
| 2026-08-27 | Efficacy | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2026-08-27 | Efficacy | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2026-08-26 | Efficacy | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2026-02-25 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2026-01-20 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2026-01-20 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2026-01-07 | Manufacturing (CMC) | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2026-01-07 | Manufacturing (CMC) | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2025-12-19 | Efficacy | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2025-09-25 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2025-09-25 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2025-05-28 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2025-02-07 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-12-20 | Efficacy | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-11-01 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2024-11-01 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2024-11-01 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
| 2024-10-18 | Efficacy | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-10-18 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-10-18 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-10-18 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-10-18 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2024-03-28 | Labeling | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2023-11-08 | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated original | ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | NDA217806 · label |
| 2023-07-28 | Labeling | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | NDA215866 · label |
Indications under study
Acute Ischemic Stroke (AIS); Acute Lymphoblastic Leukemia; Adrenalectomy; Status; Adult Congenital Heart Disease; Aging; Alcohol; Alcohol Abuse/Dependence; Alcohol Dependence; Alcohol Use Disorder; Alcohol Use Disorder (AUD); Alcoholism; Atherosclerosis; Atherosclerosis Cardiovascular Disease; Atrial Fibrillation; Autosomal Dominant Polycystic Kidney; BMI Greater Than 30; Bariatric Surgery; Binge Eating Disorder; Bowel Diseases, Inflammatory; Breast Cancer; Breast Cancers; Breast Neoplasms; COPD; Cannabis Use Disorder; Cannabis Use Disorder, Moderate; Cannabis Use Disorder, Severe; Cardiovascular Function; Catheter Ablation; Central Centrifugal Cicatricial Alopecia (CCCA); Chronic Coronary Artery Disease; Cocaine Use Disorder; Comorbidities and Coexisting Conditions; Coronary Artery Disease; Coronary Microvascular Dysfunction; Crohn Disease; Crohn Disease (CD); Crohn's Disease; Diabete Mellitus; Diabetes; Diabetes Mellitus.
Recent papers
Headlines
Every tirzepatide trial on file
All 143 registered trials of tirzepatide, largest first. Each links to its own page and to the registry record.