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AZD6234

Clinical trials are investigating AZD6234 as part of studies for weight loss in people with obesity or overweight. These trials look at safety, tolerability, and how well AZD6234 works alone or with AZD9550. The studies include adults with obesity or overweight, with or without type 2 diabetes.

Table of contents

Trial overview

Two authorised clinical trials are investigating AZD6234 in people with obesity or overweight.[1][2] One study is a Phase 2 weight loss trial, and the other is an early-phase study that includes Phase 1 and Phase I/II parts.[1][2]

The studies are focused on weight management and on checking how safe and tolerable the study treatments are.[1][2] One trial studies AZD6234 together with AZD9550, while the other looks at AZD6234 as part of a co-administration study with AZD9550.[1][2]

Who can join the studies

The Phase 2 study includes people with obesity or overweight condition correlated to many co-morbidities.[1] A co-morbidity is another health problem that happens along with the main condition.

The Phase 1 / Phase I/II study includes participants living with obesity and overweight, with or without type 2 diabetes mellitus.[2] This means the study is not limited to people with diabetes, but it can include them.[2]

What is being measured

In the Phase 2 study, the main outcomes are percent change in body weight from baseline after 36 weeks of treatment and the proportion of participants who lose at least 5% of body weight after 36 weeks.[1] Baseline means the starting point before treatment begins.

The early-phase study mainly measures safety and tolerability through adverse events, serious adverse events, vital signs, ECG, and clinical laboratory tests.[2] It also measures pharmacokinetics in part of the study, which describes how the body handles the treatment over time.[2]

Trial phases and study design

The Phase 2 study is an interventional trial, which means the researchers give study treatments and then measure the results.[1] It has an enrollment of 360 participants and is currently authorised.[1]

The other study is also interventional and is described as a Phase I/II, randomised, single-blind, placebo-controlled, multiple-ascending-dose study.[2] Randomised means participants are assigned by chance, single-blind means not everyone knows which treatment is given, placebo-controlled means a dummy treatment is used for comparison, and multiple-ascending-dose means the dose is increased in steps across groups.[2]

This early study has an enrollment of 176 participants and is also authorised.[2] Its design is meant to build early evidence on safety before larger studies move forward.[2]

Study treatments and comparison groups

In the Phase 2 study, AZD6234 is tested in combination with AZD9550 against placebo, and the study also compares each drug alone in the trial design described in the title.[1] This helps researchers see whether the combination works better than no active treatment.[1]

In the early-phase study, participants receive AZD9550 alone or AZD9550 together with AZD6234, with matching placebo groups for comparison.[2] The trial also includes different parts that test repeat dosing and multiple dose increases.[2]

The trial records list several supporting medicines and test materials, but the main study focus for this article is the AZD6234 research program and its comparison groups.[1][2]

What the trial data show so far

Both studies are currently listed as Authorised, which means they have approval to run based on the trial data provided.[1][2] The available information shows that AZD6234 is being studied for weight loss in adults with obesity or overweight, including some people with type 2 diabetes.[1][2]

At this stage, the key question is whether AZD6234, especially when used with AZD9550, can help reduce body weight while remaining safe and tolerable in the study groups.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT06862791 Phase 2 Obesity or overweight condition correlated to many co-morbidities Authorised 360
2023-504215-32-00 Phase 1 / Phase I/II Overweight and obesity, with or without type 2 diabetes mellitus Authorised 176

FAQ

  • What is being studied in AZD6234 trials? The trials are studying AZD6234 alone and together with AZD9550. They are mainly looking at weight loss and at safety-related measures such as vital signs, ECG, and lab tests.
  • Who can take part in these studies? The studies include participants living with obesity or overweight. One study also includes people with or without type 2 diabetes mellitus.
  • What phases are the AZD6234 trials in? The trial data includes a Phase 2 study and a Phase 1 study. The Phase 1 study also includes Phase I/II parts in its title.
  • What results are the trials measuring? The main results include percent change in body weight after 36 weeks and the number of people who lose at least 5% of body weight. The other study measures safety, tolerability, pharmacokinetics, and pharmacodynamics.
  • Are the AZD6234 studies recruiting people now? Both trials are listed as Authorised. This means they have been approved to run, based on the trial data provided.

Ongoing Clinical Trials on AZD6234

  • Study of AZD9550 and AZD6234 combination for weight loss in people with obesity or overweight with health complications

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Safety and Effects of AZD9550 for Overweight and Obese Patients with Non-Alcoholic Steatohepatitis (NASH) with or without Type 2 Diabetes

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Sweden

Glossary

  • Obesity: A long-term condition where a person has too much body fat, which can raise the risk of other health problems.
  • Overweight: A body weight that is above the healthy range for a person’s height.
  • Type 2 diabetes mellitus: A condition where the body does not use insulin well, causing high blood sugar.
  • Placebo: An inactive treatment that looks like the study drug but does not contain the active medicine.
  • Phase 1: An early trial phase that mainly checks safety, tolerability, and how the body handles the study treatment.
  • Phase 2: A trial phase that looks more closely at whether the treatment works and continues safety checks.
  • Safety: How well a treatment can be used without causing harmful problems.
  • Tolerability: How well people can handle a treatment, including how troublesome side effects are.
  • Pharmacokinetics: How the body absorbs, moves, breaks down, and removes a treatment.
  • Pharmacodynamics: How a treatment affects the body.
  • ECG: A test that records the heart’s electrical activity.
  • AEs and SAEs: AEs are adverse events, or unwanted medical problems during a study. SAEs are serious adverse events, which are more severe or dangerous.

References