amylin long acting (AZD6234) / AstraZeneca - LARVOL DELTA

...AstraZeneca’s broader weight loss portfolio also includes the long-acting amylin AZD6234, which is due to read out phase 2 data in the first half of 2026. (FierceBiotech) - "Meanwhile, a phase 2 study of a combination of AZD6234 with the dual GLP-1 and glucagon agonist AZD9550 is due to read out in the second half of the year."

P2 data • Obesity

A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jul 2026 ➔ Dec 2026 | Trial primary completion date: Jul 2026 ➔ Dec 2026

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

CONTEMPO: A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight (clinicaltrials.gov) - P1/2 | N=118 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Mar 2027 | Trial primary completion date: Jul 2026 ➔ Mar 2027

Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • DPP4

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

Trial completion • Genetic Disorders • Obesity

Co-Administration of GLP-1R/GCGR and Amylin Receptor Agonists Improves Body Weight in DIO Rats (OBESITY WEEK 2025) - "We aimed to evaluate the combination effects of AZD6234 and the GLP-1R/GCGR agonist cotadutide (cota) on BW gain in obese (DIO) rats, and acute effects on GE in chow fed rats. DIO rats treated with a combination of AZD6234 and cota displayed an additive effect on decreasing BW gain vs. monotherapy accompanied by a decrease in peri-renal fat pad and liver weights. Treatment with AZD6234 or cota showed an expected decrease in GE in dose-dependent manner, and an additional effect on GE was observed with combination treatment at sub-maximal doses as compared to monotherapy."

Preclinical • Genetic Disorders • Obesity

A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jan 2026 ➔ Jul 2026 | Trial primary completion date: Jan 2026 ➔ Jul 2026

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

Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234 (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: AstraZeneca | N=100 ➔ 24 | Trial completion date: Jan 2026 ➔ Sep 2025 | Trial primary completion date: Jan 2026 ➔ Sep 2025 | Recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Renal Disease

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=103 | Active, not recruiting | Sponsor: AstraZeneca | N=52 ➔ 103

Enrollment change • Genetic Disorders • Obesity

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=377 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234 (clinicaltrials.gov) - P1 | N=21 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Genetic Disorders • Obesity

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 | Trial completion date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Feb 2026 ➔ Jul 2026

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

AZD234, a novel selective amylin receptor agonist (SARA), demonstrates a preferential profile over DACRA or GLP-1R agonist in rat models of aversion and fat-mass loss (EASD 2025) - "Our data indicate that AZD6234, a potent SARA, elicited fat-mass specific weight loss with preservation of lean-mass in DIO rats. In lean rats, aversion correlated to calcitonin receptor engagement and in DIO rats lean mass loss also correlated to calcitonin receptor engagement. AZD6234 mediated significant delay in gastric emptying which unlike GLP-1RA was maintained beyond 7 days."

Preclinical • Metabolic Disorders • Obesity

A Study to Investigate the Effect of AZD6234 and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: AstraZeneca | N=25 ➔ 50

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=52 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=142 ➔ 52

Enrollment change • Enrollment closed • Genetic Disorders • Obesity

A Study to Assess the Impact of Multiple Doses of AZD6234 on a Single Dose of Combined Oral Contraceptive in Female Participants (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

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) - "Treatment with AZD6234 and semaglutide showed similar BW loss, but AZD6234 treatment led to more fat mass loss with the preservation of lean mass. Combined treatment led to additive effects on suppression of food intake, BW and fat mass loss."

Combination therapy • Preclinical • Metabolic Disorders • Obesity

This is a Multi-centre, Multi-drug, Platform Study in Chinese Participants Living With Obesity/Overweight (clinicaltrials.gov) - P2 | N=871 | Recruiting | Sponsor: AstraZeneca

New P2 trial • Genetic Disorders • Obesity

A Study to Assess the Impact of Multiple Doses of AZD6234 on a Single Dose of Combined Oral Contraceptive in Female Participants (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: AstraZeneca

New P1 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 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • 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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

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