LY3537021 / Eli Lilly - LARVOL DELTA

J2R-MC-YAAD: A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Eli Lilly and Company | N=77 ➔ 204

Enrollment change • Trial initiation date • Chemotherapy-Induced Nausea and Vomiting • Oncology

J2R-MC-YAAD: A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer (clinicaltrialsregister.eu) - P1/2 | N=30 | Not yet recruiting | Sponsor: Eli Lilly & Co.

New P1/2 trial • Chemotherapy-Induced Nausea and Vomiting • Oncology

J2R-MC-YAAD: A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer (clinicaltrials.gov) - P2 | N=77 | Recruiting | Sponsor: Eli Lilly and Company | N=58 ➔ 77

Enrollment change • Chemotherapy-Induced Nausea and Vomiting • Oncology

A phase 2 randomized, double-blind, placebo-controlled study to evaluate LY3537021 for the treatment of chemotherapy-induced nausea and vomiting in patients with malignant disease. (ASCO-GI 2026) - P2 | "Background: Chemotherapy-induced nausea and vomiting (CINV) remains an important concern for patients (pts) receiving highly emetogenic regimens such as anthracycline, cyclophosphamide (AC) and cisplatin. Other inclusion criteria are adequate hematologic, hepatic, renal, and pancreatic function, and agreement to contraception requirements. Exclusion criteria include the presence of symptomatic or untreated CNS metastases, hypersensitivity to antiemetics, uncontrolled diabetes (HbA1c ≥8%), significant cardiac disorders, QTcF prolongation, thyroid abnormalities, active HBV, HCV, HIV, or CMV infection, alternative causes for nausea/vomiting, or prior systemic anticancer therapy."

CINV • Clinical • P2 data • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Long-acting GIPR agonist LY3537021 reduces body weight and fasting blood glucose in patients with T2D: Preclinical development and phase 1 randomized ascending dose studies. (PubMed, Mol Metab) - P1 | "In vivo studies demonstrated that LY3537021 reduced body weight and improved glycemia during a glucose challenge in rats. The phase 1 study demonstrated that the long-acting GIPR agonist LY3537021 was well tolerated, induced weight loss, and improved glucose control in humans. These observations better define the therapeutic benefit of long-acting GIPR agonists and support a distinct contribution of GIP agonism to the benefits observed with multi-agonist peptides that act via the GIPR. Future studies are needed in more diverse populations and in cohorts with overweight/obesity to confirm these findings."

Journal • P1 data • Preclinical • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Chemotherapy-Induced Nausea and Vomiting • Oncology

A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer (clinicaltrials.gov) - P2 | N=204 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Chemotherapy-Induced Nausea and Vomiting • Oncology

A long-acting glucose-dependent insulinotropic polypeptide receptor agonist improves gastrointestinal tolerability of glucagon-like peptide 1 receptor agonist therapy (EASD 2023) - P1 | "Supported By Eli Lilly and Company Clinical Trial Registration Number NCT05444569 Background and aims: The contributions of glucose-dependent insulinotropic polypeptide (GIP) receptor activation to the overall benefit of tirzepatide, which activates both the glucagon-like peptide 1 (GLP-1) receptor and the GIP receptor, are incompletely understood...This study evaluated the safety and tolerability profile of LY3537021 (LY) in combination with liraglutide, in order to evaluate potential mitigation of liraglutide-related gastrointestinal (GI) adverse events... These results suggest that long-acting GIP receptor agonism may enable improvement in tolerability to the GI adverse events associated with GLP-1 receptor agonist therapy, which may contribute to the improved clinical benefits noted with long-acting GIP/GLP-1 receptor co-agonism."

Metabolic Disorders

A Long-Acting Glucose-Dependent Insulinotropic Polypeptide Receptor Agonist Shows Weight Loss without Nausea or Vomiting (ADA 2023) - "Weight loss efficacy has been observed with glucagon-like peptide 1 (GLP-1) and GIP receptor agonist tirzepatide, but weight loss efficacy has also been observed with GLP-1 agonism mixed with GIP antagonism.LY3537021 (LY), a selective, long-acting GIP receptor agonist, was tested in single [SAD, LY vs placebo (PBO)] and multiple ascending doses (MAD, LY vs PBO once weekly for 4 weeks) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics.In SAD, healthy participants (N=39) had a mean age of 43.5 yrs and mean weight of 74.4 kg. No nausea or vomiting was observed.Repeated dosing of a long-acting GIP receptor agonist, once weekly for 4 weeks, induced weight loss without gastric emptying delay or nausea and vomiting. The results suggest that GIP agonism can contribute to weight loss effects seen with multi-agonist incretins such as tirzepatide."

Hypoglycemia • Metabolic Disorders

A Study of LY3537021 in Healthy Participants (clinicaltrials.gov) - P1 | N=47 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

A Study of LY3537021 in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of LY3537021 in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of LY3537021 in Healthy Participants (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial

A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1; N=85; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus