104 Participants NeededMy employer runs this trial

AZD1043 for Obesity

Recruiting at 2 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called AZD1043 to assess its safety and behavior in the body for individuals with overweight or obesity. Researchers aim to understand how the body processes the drug and identify any side effects. Participants will receive either a single or multiple doses of AZD1043 or a placebo (a harmless pill with no effect) for comparison. The study is open to healthy adults with a body mass index (BMI) between 25 and 39.9 who have not recently taken weight loss medications. Individuals of Japanese and Chinese descent are especially encouraged to join certain parts of the trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken any weight loss medications in the last 3 months before the screening.

Is there any evidence suggesting that AZD1043 is likely to be safe for humans?

Research shows that AZD1043 is being tested for safety and tolerance in people who are overweight or obese. Since this study is in the early stages, it primarily assesses how well adults handle the treatment. This phase is crucial for identifying any potential side effects, though detailed safety information is still being gathered. So far, no specific negative effects have been widely reported. However, researchers aim to closely monitor participants to quickly identify and manage any reactions. This approach enhances understanding of the treatment's safety as further studies are conducted.12345

Why do researchers think this study treatment might be promising for obesity?

AZD1043 is unique because it offers a fresh approach to tackling obesity by potentially targeting different pathways than existing treatments. Most current obesity treatments focus on appetite suppression or calorie absorption reduction, but AZD1043 may work by directly influencing metabolic processes, which could lead to more effective weight management. Researchers are excited about this treatment because it could provide quicker and more sustainable results with fewer side effects, offering a promising alternative to traditional options like orlistat or phentermine.

What evidence suggests that AZD1043 might be an effective treatment for obesity?

Research has shown that AZD1043 might help people with obesity lose body fat. In this trial, participants will receive varying dosages of AZD1043 or a placebo. One study found that a specific dosage led to a loss of more than 5% of body fat while maintaining muscle loss below 0.5%. This indicates that participants primarily lost fat while preserving muscle. These early results are promising, but further research is needed to confirm its effectiveness.12367

Are You a Good Fit for This Trial?

This trial is for healthy adults who are overweight or have obesity (BMI between 25–39.9, or slightly lower for Japanese/Chinese participants), weigh at least 50 kg, and meet specific ancestry requirements if joining the Japanese or Chinese groups. Women must not be pregnant and some must show proof they can't become pregnant.

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.
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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

Trial Overview

The study tests different doses of a new drug called AZD1043 compared to a placebo in healthy overweight or obese adults, including those of Japanese and Chinese descent. The main goal is to see how safe the drug is and how it behaves in the body after single and multiple doses.

How Is the Trial Designed?

13

Treatment groups

Experimental Treatment

Group I: Part B2 (Japanese MAD): Cohort 1 - AZD1043 (Dose D)Experimental Treatment2 Interventions
Group II: Part B1 (Global MAD): Cohort 3 - AZD1043 (Dose C)Experimental Treatment2 Interventions
Group III: Part B1 (Global MAD): Cohort 2 - AZD1043 (Dose B)Experimental Treatment2 Interventions
Group IV: Part B1 (Global MAD): Cohort 1 - AZD1043 (Dose A)Experimental Treatment2 Interventions
Group V: Part A3 (Chinese SAD): Cohort 1 - AZD1043 (Dose Z)Experimental Treatment2 Interventions
Group VI: Part A2 (Japanese SAD): Cohort 2 - AZD1043 (Dose Y)Experimental Treatment2 Interventions
Group VII: Part A2 (Japanese SAD): Cohort 1 - AZD1043 (Dose X)Experimental Treatment2 Interventions
Group VIII: Part A1 (Global SAD): Cohort 6 - AZD1043 (Dose 6)Experimental Treatment2 Interventions
Group IX: Part A1 (Global SAD): Cohort 5 - AZD1043 (Dose 5)Experimental Treatment2 Interventions
Group X: Part A1 (Global SAD): Cohort 4 - AZD1043 (Dose 4)Experimental Treatment2 Interventions
Group XI: Part A1 (Global SAD): Cohort 3 - AZD1043 (Dose 3)Experimental Treatment2 Interventions
Group XII: Part A1 (Global SAD): Cohort 2 - AZD1043 (Dose 2)Experimental Treatment2 Interventions
Group XIII: Part A1 (Global SAD): Cohort 1 - AZD1043 (Dose 1)Experimental Treatment2 Interventions

Find a Clinic Near You

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 profile image

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 profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

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