CK-0045 / Cytoki Pharma, Novo Nordisk - LARVOL DELTA

A Phase 1, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study of the Novel Lipidated IL-22 Receptor Agonist CK-0045 in Adults with and without Obesity (ADA 2025) - "This Phase 1 study of the novel lipidated IL-22 agonist CK-0045 identified safe and tolerable doses with promising exploratory efficacy trends despite high baseline variability and short treatment duration."

Clinical • P1 data • Metabolic Disorders • Obesity • IL22

CK-0045 Proof-of-concept Study in Participants With Overweight / Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Cytoki Pharma | Trial completion date: Oct 2025 ➔ Jan 2026

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

Cytoki Pharma Highlights Data Reinforcing Therapeutic Potential of Lipidated IL-22 for IBD in Digestive Diseases and Sciences Publication (PRNewswire) - "Results strongly support continued development of Cytoki's oral IL-22 program for UC which is part of its growing preclinical pipeline of IL-22-based assets....Cytoki Pharma ApS...today announced the publication of preclinical data demonstrating the efficacy of its novel lipidated IL-22 analogue in a model of inflammatory bowel disease (IBD) in Digestive Diseases and Sciences....Preclinical results also highlighted lipidated IL-22's ability to directly induce mucosal healing and reduce inflammation, further demonstrating IL-22's unique ability when compared to existing IBD treatments. Notably, the combination of lipidated IL-22 with immunomodulatory agents resulted in additive therapeutic benefits, signaling potential for even greater improvements when used in combination."

Preclinical • Inflammatory Bowel Disease • Ulcerative Colitis

CK-0045 Proof-of-concept Study in Participants With Overweight / Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Cytoki Pharma

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity (clinicaltrials.gov) - P1 | N=76 | Completed | Sponsor: Cytoki Pharma | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity (clinicaltrials.gov) - P1 | N=76 | Active, not recruiting | Sponsor: Cytoki Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Cytoki Pharma Presents Preclinical Data Demonstrating Weight Reduction and Improved Glucose Control with Lipidated IL-22 at ObesityWeek 2023 (PRNewswire) - "Cytoki Pharma, ApS (Cytoki)...today presented preclinical data demonstrating the potential of lipidated IL-22 to induce weight loss and positively impact a range of cardiometabolic risk factors at ObesityWeek 2023, held October 14-17 in Dallas....The data presented show that subcutaneous (SC) dosing of diet-induced obese (DIO) mice with lipidated IL-22 for five weeks resulted in dose-dependent reductions in body weight of up to 20.2% at the highest dose—a comparable reduction in mass as observed with optimally dosed GLP-1 receptor agonist (GLP-1RA) semaglutide (25.2%)....CK-0045...is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 1 study....The study will include a maximum of 88 participants across the single and multiple ascending dose cohorts. Data from the study is anticipated in the first half of 2024."

P1 data • Preclinical • Metabolic Disorders • Obesity

A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants and Otherwise Healthy Participants With Obesity (clinicaltrials.gov) - P1 | N=88 | Recruiting | Sponsor: Cytoki Pharma | Trial completion date: Dec 2023 ➔ Apr 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

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

A Phase 1 Study to Investigate Safety, Tolerability, and Pharmacokinetics of CK-0045 in Healthy Participants (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Cytoki Pharma

New P1 trial