K-833 / Kallyope - LARVOL DELTA

Combined GPR40 and GPR119 full agonism with K-757 and K-833 results in robust glucose lowering and modest weight loss in overweight/obese subjects with T2DM. (PubMed, Diabetes Obes Metab) - "Co-agonism of GPR40 and GPR119 with K-757 and K-833 elicits rapid, robust and glucose-dependent glucose lowering and modest weight loss in patients with T2DM on stable metformin."

Clinical • Journal • Genetic Disorders • Obesity • Type 2 Diabetes Mellitus

Discovery of Gut-Targeted GPR40 Agonist K-757 and GPR119 Agonist K-833, a Combination Treatment for Metabolic Disorders. (PubMed, J Med Chem) - "In preclinical studies, administration of GPR40 agonist K-757 in combination with GPR119 agonist K-833 resulted in robust increases in the level of circulating hormones. In initial clinical studies, pharmacokinetics and pharmacodynamics for each molecule were characterized and largely recapitulated the effects of the individual compounds in mice."

Journal • Metabolic Disorders

Kallyope seems to shift gears to focus on neuro after disappointing weight loss data (Firstwordpharma Press Release) - P2 | N=155 | NCT06019559 | Sponsor: Kallyope Inc. | "The changes on the company's website were spotted this week after the results of a Phase II obesity study were quietly posted to ClinicalTrials.gov...While the combination of Kallyope's two oral 'nutrient receptor agonists' K-757 and K-833 may have demonstrated a more tolerable gastrointestinal (GI) profile than other oral contenders, the rate of weight loss seen in the study falls well short of the levels achieved by the pack leader...After 13 weeks, K-757 led to a 1.57% reduction in weight from baseline, while patients who received the duo saw a 2.94% decline; those in the placebo arm had a 0.15% reduction....Of the 52 patients who received K-757 plus K-833, 14 discontinued treatment due to an adverse event (AE)....K-833 is no longer listed on Kallyope's pipeline, leaving K-757 as the sole disclosed metabolic candidate."

Discontinued • P2 data • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Kallyope Inc. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=32 | Active, not recruiting | Sponsor: Kallyope Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Kallyope Inc.

New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 (clinicaltrials.gov) - P2 | N=150 | Completed | Sponsor: Kallyope Inc. | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Kallyope Inc.

Combination therapy • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Kallyope Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Kallyope Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Kallyope Inc. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Kallyope Enters Phase 2 With First-in-class Oral Approach for the Treatment of Both Obesity and Type 2 Diabetes (Businesswire) - "Kallyope, Inc...announced the initiation of their Phase 2 trial evaluating K-757 and K-833, new oral nutrient receptor agonists being studied for obesity and Type 2 diabetes. The trial, K-757 P006, aims to demonstrate the weight-loss efficacy, safety, and tolerability of these novel agents for patients with obesity, a growing epidemic in the United States."

Trial status • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Tolerability, and Weight Loss Efficacy of K-757 Alone and in Combination With K-833 (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Kallyope Inc.

Combination therapy • New P2 trial • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Kallyope Inc.

New P1 trial • Genetic Disorders • Obesity

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Kallyope Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Kallyope Inc.

New P1 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus