LY3541105 / Eli Lilly - LARVOL DELTA

Dual amylin and calcitonin receptor agonist colulintide (LY3541105) increased cortisol in a phase 1 study (ECO 2025) - "Parts B and C showed dose and drug-concentration dependent increases beyond the upper limit of normal in salivary cortisol, an indication of hypercortisolism that was confirmed with measures of 24-h urinary cortisol and a dexamethasone suppression test in Part C (table)... In this phase 1 study, colulintide showed evidence of dose-dependent hypercortisolism associated with increased bone resorption and decreased bone formation. It is unknown whether these findings are molecule-specific or could be related to the mechanism of action."

P1 data • Genetic Disorders • Obesity

Safety, pharmacokinetics and pharmacodynamics of dual amylin and calcitonin receptor agonist colulintide (LY3541105) for chronic weight management: a phase 1 study (ECO 2025) - "Colulintide caused dose-dependent weight loss and GI AEs, consistent with non-selective amylin and calcitonin receptor agonists. Colulintide was associated with psychiatric disorder domain AEs which led to discontinuation of dose escalation. It is unknown whether these findings are molecule-specific or could be related to the mechanism of action."

Clinical • P1 data • PK/PD data • Cardiovascular • CNS Disorders • Fatigue • Genetic Disorders • Heart Failure • Mental Retardation • Mood Disorders • Obesity • Pain • Psychiatry • Suicidal Ideation

UPDATED: Eli Lilly lops Alzheimer's and obesity assets from pipeline in Q4 update (FierceBiotech) - "Eli Lilly has thinned its pipeline in two critical therapeutic areas, axing clinical-phase Alzheimer’s disease and obesity candidates as part of its quarterly clear-out...The removal of ceperognastat, Lilly’s oral O-GlcNAcase anti-tau agent, from the pipeline comes months after the candidate failed...to slow clinical decline in early symptomatic Alzheimer’s disease patients in a phase 2 trial....Lilly removed the candidate, which it called DACRA QW II and LY3541105, from its pipeline Thursday."

Discontinued • Alzheimer's Disease • Obesity

A Study of LY3541105 in Healthy and Overweight Participants (clinicaltrials.gov) - P1 | N=206 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Obesity

A Study of LY3541105 in Healthy and Overweight Participants (clinicaltrials.gov) - P1 | N=205 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Obesity

A Study of LY3541105 in Healthy and Overweight Participants (clinicaltrials.gov) - P1 | N=205 | Recruiting | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Recruiting

Enrollment open • Obesity

A Study of LY3541105 in Healthy and Overweight Participants (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Recruiting | Trial completion date: Mar 2024 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Enrollment open • Trial completion date • Trial primary completion date • Obesity

A Study of LY3541105 in Healthy and Overweight Participants (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Oct 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Obesity