LY3537021 for Nausea and Vomiting from Chemotherapy

Not yet recruiting at 71 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must not be taking: Antiemetics, GIP, GLP-1

Disqualifiers: CNS metastases, Uncontrolled diabetes, Cardiac conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a new treatment, LY3537021, for managing chemotherapy-induced nausea and vomiting. Participants will receive either this treatment with standard anti-nausea drugs or a placebo with the same standard drugs to determine if LY3537021 provides better relief. The trial seeks individuals who have not yet started chemotherapy but are about to receive specific types. Interested participants should not have other causes for nausea or certain untreated health issues. The study will last about two months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications with antiemetic activity (medications that prevent nausea and vomiting) or certain diabetes medications within 4 weeks before starting chemotherapy.

Is there any evidence suggesting that LY3537021 is likely to be safe for humans?

Research has shown that LY3537021 has been tested in earlier studies to assess its safety and tolerability. In one study, researchers administered both single and multiple doses of LY3537021 to healthy individuals and patients. The results indicated that the treatment was generally well-tolerated, with most side effects being mild to moderate. These findings suggest that LY3537021 might be safe for treating nausea and vomiting caused by chemotherapy, but ongoing studies will provide more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for nausea and vomiting?

Unlike the standard care options for nausea and vomiting from chemotherapy, which typically include medications like ondansetron and metoclopramide, LY3537021 is unique because it is administered subcutaneously, which can offer a different delivery method and potentially improve absorption and effectiveness. Researchers are excited about LY3537021 because it works in combination with existing antiemetic therapies, providing an innovative approach that could enhance their efficacy. This combination might offer better protection against the severe side effects of chemotherapy, making the treatment process more manageable for patients.

What evidence suggests that LY3537021 might be an effective treatment for nausea and vomiting from chemotherapy?

Research has shown that LY3537021, which participants in this trial may receive, may help reduce nausea and vomiting caused by chemotherapy. Studies have found that GIP agonists, like LY3537021, ease these symptoms by affecting certain pathways in the body. In one study, fewer people experienced nausea or vomiting when treated with LY3537021 compared to those who did not receive it. Specifically, 25% of participants on LY3537021 reported nausea or vomiting, while 37% of those not on the treatment did. These findings suggest LY3537021 might be a promising option for managing chemotherapy-induced nausea and vomiting. ^{1 2 3 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with cancer who are experiencing nausea and vomiting due to chemotherapy. Participants should not have unexplained vomiting unrelated to treatment or adverse reactions that would interfere with the study.

Inclusion Criteria

I have not had chemotherapy before and am scheduled for specific chemo treatments without multiple doses in the first 5 days.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 half-lives, whichever is longer, of C1D1

Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention

I have brain metastases that are causing symptoms or have not been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3537021 or placebo with standard antiemetic therapies prior to chemotherapy

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3537021

Trial Overview The study tests LY3537021's effectiveness in controlling chemo-induced nausea/vomiting, comparing it against a placebo and standard antiemetic therapies alongside regular chemotherapy.

How Is the Trial Designed?

Group I: LY3537021 + Antiemetic Therapies Experimental Treatment 3 Interventions

Prior to chemotherapy, participants receive LY3537021 administered subcutaneously (SC) with standard of care (SOC) antiemetic therapies orally, intravenously (IV), or transdermally, per local label

Group II: Placebo + Antiemetic Therapies Placebo Group 3 Interventions

Prior to chemotherapy, participants receive placebo administered SC with SOC antiemetic therapies orally, IV, or transdermally, per local label

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07169851

NCT07169851 | A Study to Evaluate LY3537021 for the ... The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy.

2. withpower.com withpower.com/trial/phase-2-vomiting-9-2025-574be

LY3537021 for Nausea and Vomiting from Chemotherapy The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy.

3. tipranks.com tipranks.com/news/company-announcements/eli-lillys-new-study-a-potential-breakthrough-in-chemotherapy-induced-nausea-treatment

Eli Lilly's New Study: A Potential Breakthrough in ... ' The study aims to assess the effectiveness and safety of LY3537021 in managing nausea and vomiting caused by chemotherapy, a significant ...

4. linkedin.com linkedin.com/posts/oliver-overheu_whac-a-nausea-lillys-new-hammer-a-recent-activity-7373690894601969665-L2-G

Lilly launches Phase II trial for CINV treatment with GIP ... Early data suggest GIP agonists can reduce chemotherapy-induced nausea. It's a smart move to repurpose a metabolic disease platform – where we' ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/pdf/10.1111/dom.15875

A long‐acting glucose‐dependent insulinotropic polypeptide ... Overall, 8/32 partici- pants (25%) experienced at least one nausea or vomiting TEAE when treated with LY, as opposed to 12/32 participants (37. ...

6. synapse.patsnap.com synapse.patsnap.com/drug/9c02402d6abc4faab6a07e340ee60adf

LY-3537021 - Drug Targets, Indications, Patents A single- and multiple-ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of LY3537021 in healthy participants and patients with ...

7. clinconnect.io clinconnect.io/trials/NCT07169851

A Study to Evaluate LY3537021 for the Treatment of The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy.