LY3537021 / Eli Lilly - LARVOL DELTA

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