AZD5004 / Eccogene, AstraZeneca - LARVOL DELTA

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (clinicaltrials.gov) - P1 | N=51 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

SOLSTICE: Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. (clinicaltrials.gov) - P2 | N=406 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

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

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Eccogene | Active, not recruiting ➔ Completed

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

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (clinicaltrials.gov) - P1 | N=51 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

VISTA: Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=310 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Eccogene | Trial completion date: May 2026 ➔ Dec 2025

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

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=49 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

AZD5004: Data from P2b VISTA trial (NCT06579092) for obesity in H1 2026 (AstraZeneca) - H1 and Q2 2025 Results: Data from P1 trial (NCT06988553) in participants with overweight/obesity with/without T2D in H1 2026

P1 data • P2b data • Obesity

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Eccogene | Recruiting ➔ Active, not recruiting

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

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Investigate the Impact of Multiple Doses of Itraconazole on AZD5004 in Healthy Participants and Multiple Doses of AZD5004 on Combined Oral Ethinyl Oestradiol and Levonorgestrel in Healthy Female Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Eccogene | Not yet recruiting ➔ Recruiting

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

Eccogene Announces First Patient Dosed in Phase 1b Trial of AZD5004/ECC5004, a Novel Oral GLP-1 Receptor Agonist, in China (GlobeNewswire) - "Eccogene...announced that the first patient has been dosed in a Phase 1b clinical trial of AZD5004/ECC5004 in China. The earlier Phase 1 trial of AZD5004/ECC5004 was conducted in the U.S. only and this trial in China is a key milestone to support local regulatory requirements. AZD5004/ECC5004 is an investigational oral small molecule GLP-1 receptor agonist, which is currently being investigated for the treatment of type 2 diabetes and obesity or overweight with at least one comorbidity."

Trial status • Obesity • Type 2 Diabetes Mellitus

SOLSTICE: Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. (clinicaltrials.gov) - P2 | N=406 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

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

A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004 (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion • Renal Disease

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study in Healthy Participants to Investigate Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

A Phase Ib Study of AZD5004 in Chinese Participants With Overweight/Obesity With or Without Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Eccogene

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

A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004 (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

AstraZeneca exits neuroscience R&D to focus on obesity and immunology (Chosun Biz) - "The British global pharmaceutical company AstraZeneca (AZ) announced its strategy to withdraw from research and development (R&D) for treatments in the neuroscience field, such as Alzheimer’s disease, and focus more on obesity and immunology....Recently, AZ halted the development of ‘MEDI1814’, an amyloid beta (Aβ) antibody candidate for early Alzheimer’s disease patients, and ‘MEDI0618’, an antibody candidate for migraine treatment....AZ stated it is developing the oral obesity treatment candidate ‘AZD5004’ as a monotherapy while also considering combination therapies with existing low-molecular-weight compounds."

Discontinued • Alzheimer's Disease • Immunology • Migraine • Obesity

A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial