AZD1043 for Obesity

Recruiting at 1 trial location

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Weight loss medications

Disqualifiers: Gastrointestinal, Hepatic, Renal, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by cohort

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.

Are You a Good Fit for This Trial?

Inclusion Criteria

* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

My BMI is within the required range and I weigh at least 50 kg.

* For the Parts A2 and B2, participants should be Japanese (natives of Japan or Japanese Americans), having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 5 weeks

Treatment

Participants receive single or multiple ascending doses of AZD1043 or placebo

Varies by cohort

Safety Follow-up

Participants are monitored for safety and tolerability after receiving AZD1043

Up to 253 days

What Are the Treatments Tested in This Trial?

Interventions

• AZD1043

How Is the Trial Designed?

Group I: Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D) Experimental Treatment 2 Interventions

Japanese participants will receive multiple doses of AZD1043 or placebo.

Group II: Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD1043 or placebo.

Group III: Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD1043 or placebo.

Group IV: Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A) Experimental Treatment 2 Interventions

Participants will receive multiple doses of AZD1043 or placebo.

Group V: Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z) Experimental Treatment 2 Interventions

Chinese participants will receive a single dose of AZD1043 or placebo.

Group VI: Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD1043 or placebo.

Group VII: Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X) Experimental Treatment 2 Interventions

Japanese participants will receive a single dose of AZD1043 or placebo.

Group VIII: Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1043 (Dose 6) or placebo.

Group IX: Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1043 (Dose 5) or placebo.

Group X: Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1043 (Dose 4) or placebo.

Group XI: Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1043 (Dose 3) or placebo.

Group XII: Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1043 (Dose 2) or placebo.

Group XIII: Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1) Experimental Treatment 2 Interventions

Participants will receive a single dose of AZD1043 (Dose 1) or placebo.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland