What is the mechanism of action of this treatment?

GLP-1 receptor agonists, such as liraglutide and exenatide, work by enhancing satiety and reducing appetite, which helps in weight management. These drugs mimic the action of the natural hormone GLP-1, which is released after eating and promotes insulin secretion while inhibiting glucagon release. This dual action helps regulate blood sugar levels and reduces food intake. For healthy subjects who are overweight or obese, these mechanisms are crucial as they aid in weight loss and help prevent the onset of metabolic diseases like type 2 diabetes and cardiovascular conditions.

What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as liraglutide, exenatide, and semaglutide, are commonly associated with gastrointestinal side effects, including nausea, vomiting, and diarrhea. These symptoms are typically more pronounced at the beginning of the treatment and tend to decrease over time. Other potential side effects include an increased risk of pancreatitis and, in rodent studies, thyroid C cell tumors, although the relevance to humans is unclear. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 are generally advised against using these medications.

What prior FDA approvals exist?

GLP-1 receptor agonists, such as semaglutide and liraglutide, have been approved by the FDA for the treatment of obesity and type 2 diabetes. These medications enhance satiety and reduce appetite, leading to significant weight loss. Semaglutide, administered once weekly, and liraglutide, administered once daily, have shown efficacy in inducing weight loss in individuals with and without diabetes. These treatments are part of a broader strategy to manage weight and improve glycemic control in overweight or obese patients.

What other types of research exist?

Promising novel alternatives to GLP-1 receptor agonists for enhancing satiety and reducing appetite in healthy subjects include: 1) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. 2) Semaglutide, a GLP-1 receptor agonist, but in a higher dose formulation specifically for weight management. 3) Anamorelin, a ghrelin receptor agonist, which has shown potential in increasing appetite and lean body mass in cachexia but may have applications in controlled appetite regulation. 4) Setmelanotide, a melanocortin 4 receptor (MC4R) agonist, which targets genetic obesity and has shown promising results in reducing hunger and body weight.

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Kinase Inhibitor

AZD6234 for Obesity

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 15, day 29 and at follow up (day 43)

Summary

This trial tests a new drug called AZD6234 in healthy adults who are overweight or obese. The study aims to find the best dose and method of giving the drug by testing it under the skin and directly into a vein. Participants will be monitored closely to see how their bodies react.

Who is the study for?

This trial is for healthy, overweight or obese adults aged 18 to 55 who are not of childbearing potential. Women must be postmenopausal or surgically sterile. Participants should have a BMI between 25 and 35 kg/m2, weigh at least 50 kg, and have good veins for drawing blood. Japanese heritage participants need both parents and all grandparents to be Japanese.

What is being tested?

The study tests the safety, tolerability, and how the body processes AZD6234 in single doses compared to a placebo. Some participants will also receive acetaminophen to assess interactions. The trial involves people receiving one dose of either AZD6234 or placebo in varying amounts.

What are the potential side effects?

Potential side effects may include reactions similar to those experienced with drugs having chemical structures like AZD6234 but specific side effects are not listed as this is an early-phase trial assessing safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 15, day 29 and at follow up (day 43)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 15, day 29 and at follow up (day 43)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 15, day 29 and at follow up (day 43) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with AEs and Serious Adverse Events(SAE)

Secondary study objectives

ADA titer

Apparent total body clearance of drug from plasma (SC dosing only) (CL/F)

Apparent volume of distribution based on the terminal phase (SC dosing only) (Vz/F)

+13 more

Trial Design

8Treatment groups

Experimental Treatment

Group I: Cohort 8Experimental Treatment3 Interventions

Participants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection

Group II: Cohort 7Experimental Treatment3 Interventions

Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection

Group III: Cohort 6Experimental Treatment3 Interventions

Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection

Group IV: Cohort 5Experimental Treatment3 Interventions

One dose level for SC administration is planned to be investigated for Japanese participants only

Group V: Cohort 4Experimental Treatment3 Interventions

Participants will receive single ascending doses of AZD6234 via IV injection and matching volumes of the placebo as a solution via IV injection

Group VI: Cohort 3Experimental Treatment3 Interventions

Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection

Group VII: Cohort 2Experimental Treatment3 Interventions

Participants will receive a single dose of AZD6234 via an SC injection and matching volume of the placebo as a solution via SC injection

Group VIII: Cohort 1Experimental Treatment3 Interventions

Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD6234

2022

Completed Phase 1

~60

Placebo

1995

Completed Phase 3

~2670

Acetaminophen

2017

Completed Phase 4

~2030

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as liraglutide and exenatide, work by enhancing satiety and reducing appetite, which helps in weight management. These drugs mimic the action of the natural hormone GLP-1, which is released after eating and promotes insulin secretion while inhibiting glucagon release. This dual action helps regulate blood sugar levels and reduces food intake. For healthy subjects who are overweight or obese, these mechanisms are crucial as they aid in weight loss and help prevent the onset of metabolic diseases like type 2 diabetes and cardiovascular conditions.