AZD5004 / Eccogene, AstraZeneca - LARVOL DELTA

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 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 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

AZD5004: Data from P1 trial (NCT06857695) for healthy volunteers in H2 2025 (AstraZeneca) - Q1 2025 Results

P1 data • Obesity

AZD5004: Data from P2b VISTA trial (NCT06579092) for obesity in 2026 (AstraZeneca) - Q1 2025 Results: Data from P1 trial (NCT06555822) for healthy volunteers in H1 2025

P1 data • P2b data • Obesity

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=38 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • 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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

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 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004 (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004 (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: AstraZeneca

New P1 trial • Hepatology

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=35 | 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=21 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004 (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Renal Disease

A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=15 ➔ 31

Enrollment change • Enrollment closed

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: AstraZeneca

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

Safety, Tolerability, and Pharmacokinetics of ECC5004, an Oral Small Molecule GLP-1R Agonist (OBESITY WEEK 2024) - " A double-blind, randomized, placebo-controlled study assessed ECC5004 in healthy participants in single doses (SAD) and participants with T2DM on metformin only, (HbA1c ≥ 7.0% and ≤ 10.5%, BMI ≥ 24 and ≤ 40 kg/m2) in multiple doses (MAD). This first-in-human study demonstrated that ECC5004 has a safety and tolerability profile consistent with that observed for other small molecule GLP-1RAs and a PK profile compatible with once daily dosing. Changes in glucose levels and body weight suggest ECC5004 achieved target engagement of the GLP-1R. The data will be available for presentation at the Obesity Week meeting in November 2024."

Clinical • PK/PD data • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

AZD5004/ECC5004 a Small Molecule GLP1-RA May Be Administered Once Daily Under Fed/Fasted Conditions (OBESITY WEEK 2024) - "AZD5004/ECC5004 may be administered orally in the fasted or fed state as overall exposure and T1/2 are unaffected by food suggesting that AZD5004/ECC5004 has the potential to be a more convenient, oral, once-daily therapy for patients. A prolonged Tmax, and lower Cmax observed in the fed state has the potential to confer better tolerability, but this will need to be evaluated in larger and longer studies, which are currently in progress."

Cardiovascular • Genetic Disorders • Obesity • Type 2 Diabetes Mellitus

Non-clinical and first-in-human characterization of ECC5004/AZD5004, a novel once-daily, oral small-molecule GLP-1 receptor agonist. (PubMed, Diabetes Obes Metab) - P1 | "ECC5004 engaged the GLP-1R across the therapeutic dose range tested and had a safety and tolerability profile consistent with other GLP-1 RAs, along with a pharmacokinetic profile compatible with once-daily oral dosing. These data support continued development of ECC5004 as a potential therapy for T2DM and overweight or obesity."

Journal • P1 data • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • ARRB1

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Participants (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: AstraZeneca | Active, not recruiting ➔ Recruiting

Enrollment open

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=384 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

VISTA: Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=304 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity