SPONSOR

Eli Lilly and Company

Total Trials

Recruiting

Phases

Phase 4, Phase 3, Phase 2, Phase 1, Phase 1, Phase 2

Conditions studied: Obesity Subjective Cognitive Impairment Metabolic Dysfunction-Associated Steatotic Liver Disease Vitiligo Non-Segmental Vitiligo (NSV)Crohn's Disease Alzheimer Disease Irritable Bowel Syndrome Constipation Alcohol Use Disorder

Eli Lilly and Company is an American pharmaceutical company founded in 1876 and headquartered in Indianapolis, Indiana. Lilly has a research legacy that includes the first commercial production of insulin in the 1920s, the development of the first polio vaccine seed stock, the introduction of fluoxetine (Prozac) — one of the most prescribed antidepressants in history — and the discovery of gemcitabine for cancer. Today Lilly's clinical trial portfolio is concentrated in diabetes and obesity, oncology, immunology, and neuroscience.

In metabolic disease, Lilly's GLP-1/GIP receptor agonist tirzepatide (Mounjaro/Zepbound) has generated landmark trial data in type 2 diabetes (SURPASS program) and obesity (SURMOUNT program), with trials now expanding into heart failure, sleep apnea, non-alcoholic steatohepatitis, and chronic kidney disease. The oncology program focuses on CDK4/6 inhibition (abemaciclib/Verzenio for breast cancer), antibody-drug conjugates, and bispecific antibodies. In immunology, the IL-17 and JAK inhibition programs cover psoriasis, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel disease.

Lilly's Alzheimer's disease program is among the most substantial in the industry. Donanemab, an anti-amyloid antibody, completed the TRAILBLAZER-ALZ 2 Phase 3 trial with positive results and has received FDA accelerated approval. Lilly continues to run trials combining anti-amyloid therapy with tau-targeting agents and lifestyle interventions. The company also participates in the Alzheimer's Clinical Trials Consortium (ACTC) and A4 Study consortium for prevention-stage research.

Frequently Asked Questions — Eli Lilly and Company

What is tirzepatide and what conditions is Lilly studying it for beyond diabetes?

Tirzepatide (brand names Mounjaro for diabetes and Zepbound for obesity) is a dual GIP/GLP-1 receptor agonist administered as a weekly subcutaneous injection. In the SURPASS and SURMOUNT clinical trial programs, tirzepatide demonstrated the largest average weight reductions of any pharmacological therapy in registered trials, with some participants losing 20–22% of body weight. Lilly is now studying tirzepatide in heart failure with preserved ejection fraction (SUMMIT trial, positive), obstructive sleep apnea (SURMOUNT-OSA, positive), non-alcoholic steatohepatitis (SYNERGY-NASH), chronic kidney disease, and as a metabolic intervention prior to bariatric surgery. Phase 3 data in heart failure are among the most anticipated results in cardiovascular medicine.

What Alzheimer's disease trials is Lilly currently running?

Lilly's Alzheimer's trial program centers on donanemab, an anti-amyloid beta plaque antibody. After the TRAILBLAZER-ALZ 2 trial showed statistically significant slowing of cognitive decline in early Alzheimer's — particularly in patients with low-to-medium tau burden — Lilly received FDA accelerated approval and continues TRAILBLAZER-ALZ 3 (prevention in amyloid-positive cognitively normal adults). The company also participates in combination-therapy trials pairing donanemab with the anti-tau antibody zagotenemab and is involved in multi-arm platform trials through the Alzheimer's Clinical Trials Consortium. Patients interested in these trials typically need amyloid PET scan confirmation or CSF biomarker testing.

Does Eli Lilly conduct pediatric clinical trials?

Yes. Lilly has pediatric trial programs in several areas where adult treatments have shown efficacy. These include oncology (applying targeted agents to pediatric tumors), type 2 diabetes and obesity in adolescents (including tirzepatide and basal insulin studies in the 10–18 age range), ADHD (atomoxetine extension and successor programs), and growth hormone deficiency. Pediatric trials are often required by FDA under the Pediatric Research Equity Act when an adult indication is sought, and Lilly publishes its pediatric study reports on the FDA pediatric study disclosure database.

Eli Lilly and Company

Frequently Asked Questions — Eli Lilly and Company

Clinical Trials by Eli Lilly and Company

A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)

A Study Evaluating the Impact of P-tau217 Blood Biomarker Testing on Early Evaluation and Management of Patients Presenting With Cognitive Complaint

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

A Study of Brenipatide in Participants With Alcohol Use Disorder

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

A Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers.

A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

A Study of LY3439539 in Participants With Alzheimer's Disease

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)

A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment

FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3

Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

A Study of Mirikizumab Solution (LY3074828) in Healthy Participants

A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults