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

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called AZD9550 for individuals who are overweight or obese, with or without Type 2 Diabetes Mellitus. The study also includes participants with a liver condition known as Non-alcoholic Steatohepatitis (NASH). The treatment involves a solution for injection, which is administered under the skin. A placebo, which looks like the treatment but does not contain the active substance, is also used for comparison.

The purpose of the study is to evaluate the safety and tolerability of AZD9550 when given in different doses over a period of time. Participants will receive either the treatment or a placebo, and the study will monitor how the body processes the drug and its effects on the participants’ health. The study will be conducted in several parts, with each part focusing on different aspects of the treatment, such as its safety and how well it is tolerated by the body.

Throughout the study, participants will undergo regular health checks, including blood tests and other assessments, to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into the potential benefits and risks of AZD9550 for managing weight and related health conditions. Participants will be closely monitored by healthcare professionals to ensure their well-being during the trial.

1 initial assessment

Upon joining the study, an initial assessment is conducted to evaluate eligibility. This includes a review of medical history and a physical examination.

Blood tests are performed to measure glucose levels, insulin, and other relevant markers.

2 randomization and baseline measurements

Participants are randomly assigned to receive either the AZD9550 or a placebo. This process is single-blind, meaning participants do not know which treatment they receive.

Baseline measurements are taken, including body weight, body fat percentage, and blood tests for cholesterol and glucose levels.

3 treatment phase part a

Participants receive weekly subcutaneous injections of AZD9550 or placebo for four weeks.

Regular monitoring of vital signs and laboratory tests is conducted to assess safety and tolerability.

4 evaluation part a

After four weeks, changes in fasting glucose, insulin, and body weight are evaluated.

Participants undergo additional blood tests to measure cholesterol levels and other markers.

5 treatment phase part b

Participants continue with multiple ascending doses of AZD9550 or placebo for an additional five weeks.

Monitoring continues with regular assessments of vital signs and laboratory tests.

6 evaluation part b

At the end of five weeks, changes in body weight, glucose levels, and liver fat are assessed using imaging techniques.

Further blood tests are conducted to evaluate changes in cholesterol and other markers.

7 treatment phase part c

Participants receive the maximum tolerated dose of AZD9550 or placebo for up to 24 weeks.

Weekly subcutaneous injections are self-administered, and regular monitoring continues.

8 final evaluation

After 24 weeks, a comprehensive evaluation is conducted, including changes in body weight, glucose levels, and liver fat.

Final blood tests and imaging studies are performed to assess the overall impact of the treatment.

Who Can Join the Study?

Participants must be males or females who cannot have children, aged between 18 and 65 years at the time of screening.
Participants can have Type 2 Diabetes Mellitus (T2DM) or not. If they have T2DM, their blood sugar should be controlled with a diabetes diet and metformin, plus no more than two other treatments, with stable doses for 3 months before screening.
Participants with T2DM should have a blood test result called HbA1c between 6% and 9%. Those without T2DM should have an HbA1c of less than 6.5%.
Participants should have a Body Mass Index (BMI) between 27 and 39.9 kg/m².
Participants must use birth control methods that follow local rules for clinical studies.
Participants must provide written consent and any other required permissions before any study-related procedures, including screening tests.
Participants must be able to meet all study requirements within 60 days after signing the consent form.
Participants must have suitable veins for multiple blood draws.
Participants must be willing and able to give themselves weekly injections under the skin for Parts C and D of the study.

Who Cannot Join the Study?

Patients with other liver diseases besides Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver condition where fat builds up in the liver, not caused by alcohol.
Patients who have had a recent heart attack or stroke are excluded.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe kidney problems are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with a history of drug or alcohol abuse in the past year cannot join.
Patients with certain types of cancer are not eligible.
Patients with a known allergy to the study medication or similar drugs cannot participate.
Patients who are unable to comply with the study procedures are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
CTC Clinical Trial Consultants AB	Uppsala	Sweden
Nuvisan GmbH	Neu-Ulm	Germany
PROFIL Institut fuer Stoffwechselforschung GmbH	Neuss	Germany
Smo Md GmbH	Magdeburg	Germany
Mhsetff Uybmylaiew Ol Ghuf	Graz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	21.09.2023
Germany	Not recruiting	21.09.2023
Sweden	Not recruiting	21.09.2023

Trial locations

Investigated drugs:

AZD9550 is a medication being studied for its safety and how well it is tolerated in people who are overweight or obese, with or without type 2 diabetes. The study is looking at how the body processes the medication when given in repeated doses under the skin. The goal is to find out how safe it is and how the body reacts to different amounts of the medication over time.

Investigated diseases:

Non-alcoholic steatohepatitis (NASH) – This disease is a liver condition characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH can progress silently, often without symptoms, but over time it may lead to liver fibrosis or scarring. As the disease advances, it can result in cirrhosis, where the liver becomes severely scarred and its function is impaired. The exact cause of NASH is not fully understood, but it is often associated with obesity, insulin resistance, and metabolic syndrome. Lifestyle factors such as diet and physical activity can influence its progression.

Trial ID:

2023-504215-32-00

Protocol code:

D8460C00002

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?