amylin long acting (AZD6234) / AstraZeneca - LARVOL DELTA

ARAY: Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

Long-Acting Amylin Analog AZD6234 in Combination with the GLP-1R Agonist Semaglutide Enhances Body Weight and Fat Mass Loss in Diet-Induced Obese (DIO) Rats (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Combination therapy • Preclinical • Metabolic Disorders • Obesity

Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234 (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

ASCEND: A Weight Loss Study Evaluating Subcutaneous Treatment With AZD9550 and AZD6234 in Combination Against Placebo or Each of the Drugs Alone (clinicaltrials.gov) - P2 | N=360 | Recruiting | Sponsor: AstraZeneca

New P2 trial • Genetic Disorders • Obesity

Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234 (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Renal Disease

ARAY: Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: AstraZeneca

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

APRICUS: A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=262 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=142 | Recruiting | Sponsor: AstraZeneca | N=76 ➔ 142 | Trial completion date: Apr 2025 ➔ Feb 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

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

Amylin Receptor Agonist AZD6234 Shows Advantages Over GLP-1R Activation for Leptin Re-Sensitization (OBESITY WEEK 2024) - "When treating obese rats for two weeks with semaglutide or AZD6234, AZD6234 better restores leptin sensitization in the hypothalamus and decreases endogenous leptin levels to those seen in lean controls. AZD6234 also drives greater reduction in fat mass compared GLP-1R agonism, despite similar body weight reduction."

Genetic Disorders • Obesity • LEP

APRICUS: A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=231 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jan 2026 ➔ Oct 2025

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

Treatment With a Long-acting Amylin, AZD6234, Leads Body Weight Loss With Preservation of Lean Mass (OBESITY WEEK 2024) - "AZD6234 treatment showed fat mass specific weight loss with greater preservation of lean mass, compared to semaglutide. Cessation of either treatment showed similar body weight regain with a rebound of type of mass originally lost."

Genetic Disorders • Obesity

Safety, Tolerability, and Pharmacokinetics of AZD6234, a Long-Acting Agonist of the Amylin Receptor (OBESITY WEEK 2024) - "AZD6234 was generally well tolerated with no major safety concerns at doses up to 4.2 mg in healthy participants. The full data will be presented at the Obesity Week meeting in November 2024."

Clinical • PK/PD data • Genetic Disorders • Obesity

Characterisation of AZD6234, a novel amylin receptor selective agonist peptide, in rodent models of weight loss and aversion (EASD 2024) - "Here we characterize a synthetic long-acting pramlintide analog, that possesses the in vitro amylin/calcitonin receptor selectivity ratio to mimic native amylin. Our data indicate that AZD6234 is a potent AMY3R agonist with selectivity mimicking endogenous amylin. AZD6234 mediated dose-dependent decreases in food intake and body weight. AZD6234 (30 nmol/kg) did not significantly increase GLP-1RA-mediated CTA in rat models."

Preclinical • Metabolic Disorders • Obesity

APRICUS: A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity (clinicaltrials.gov) - P2 | N=231 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Genetic Disorders • Obesity

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: AstraZeneca | N=40 ➔ 76

Enrollment change • Genetic Disorders • Obesity

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AstraZeneca | N=68 ➔ 40 | Trial completion date: Oct 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

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

Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Obesity

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=54 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Obesity

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD6234 After Repeat Dose Administration in Participants Who Are Overweight or Obese (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Genetic Disorders • Obesity