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Study on CK-0045 for Patients with Type 2 Diabetes and Obesity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for individuals with Type 2 diabetes and obesity. The treatment being tested is called CK-0045, which is an injection given under the skin. The study will compare the effects of CK-0045 to a placebo, which is a substance with no active medication, to see how it affects blood sugar levels after eating a meal.

The purpose of the study is to understand how CK-0045 works over a period of 16 weeks. Participants will receive weekly injections of CK-0045 at different dose levels or a placebo. The study will monitor changes in blood sugar levels, body weight, and cholesterol levels, among other health indicators, to assess the treatment's safety and effectiveness.

This trial aims to provide insights into how CK-0045 can help manage blood sugar and weight in people with Type 2 diabetes and obesity. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, body mass index (BMI), and medical history related to type 2 diabetes and obesity.
Participants must have a stable treatment regimen involving diet, exercise, and a maximum of two oral antidiabetic medications for at least three months prior to joining.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes evaluating glucose metabolism through a mixed meal tolerance test (MMTT).
Other baseline measurements include body weight, cholesterol levels, and HbA1c, which is a measure of blood sugar levels over time.
Step 3
Treatment phase
Participants receive weekly subcutaneous injections of CK-0045 or a placebo for a duration of 16 weeks.
The injections are administered as a non-preserved sterile liquid formulation.
Step 4
Ongoing monitoring
Throughout the 16-week treatment period, regular monitoring is conducted to assess the effects of the treatment.
This includes tracking changes in glucose metabolism, body weight, cholesterol levels, and other relevant health indicators.
Step 5
Final assessment
At the end of the 16-week period, a final assessment is performed to evaluate the changes from baseline in the area under the plasma glucose curve after the MMTT.
Secondary outcomes such as changes in body weight, cholesterol levels, and HbA1c are also assessed.

Who can join the trial?

6 criteria

Must be a male or female diagnosed with type 2 diabetes mellitus. This is a condition where the body has trouble using insulin properly.
Must be between 18 and 74 years old at the time of signing the informed consent.
Must have a Body Mass Index (BMI) between 27.0 and 40.0 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.
Must have an HbA1c level between 6.5% and 8.5%. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
Must have been diagnosed with type 2 diabetes for at least 6 months before the screening.
Must be treated with diet and exercise and can be on a maximum of two oral antidiabetic medications, which should be at stable doses for at least 3 months before the screening.

Who cannot join the trial?

4 criteria

Individuals who do not have Type 2 diabetes or are not considered overweight or obese cannot participate.
Participants must be within the specified age range, which is typically adults.
Both male and female participants are eligible, but those who do not identify as either may not be included.
Individuals who are part of a vulnerable population, such as those unable to give informed consent, may be excluded.

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Verified sites

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CRS Clinical Research Services Mannheim GmbH
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Mannheim, Germany

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Investigated drugs

CK-0045 is an investigational medication being studied for its potential effects on glucose metabolism in people who are overweight or have obesity and Type 2 diabetes. It is administered through a weekly injection under the skin. The trial aims to assess how well this medication works, how safe it is, and how well it is tolerated by participants over a period of 16 weeks.

Ck-0045

What is already known about the treatment

CK-0045 – This medication is administered through weekly subcutaneous injections. It is currently being studied in clinical trials to assess its effectiveness, safety, and tolerability for individuals with overweight or obesity and Type 2 diabetes. The main therapeutic indications for CK-0045 are to improve glucose metabolism and assist in weight management. At the molecular level, CK-0045 works by influencing pathways involved in glucose regulation and energy balance. It is classified pharmacologically as a treatment for metabolic disorders, specifically targeting Type 2 diabetes and obesity.

Investigated diseases

Type 2 Diabetes
This is a chronic condition that affects the way the body processes blood sugar (glucose). In Type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, and fatigue. It is often associated with being overweight or obese.
Obesity
Obesity is a complex disease involving an excessive amount of body fat. It is not just a cosmetic concern but a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, and high blood pressure. Obesity occurs when a person takes in more calories than they burn through exercise and normal daily activities. It can develop over time due to a combination of genetic, behavioral, and environmental factors. Symptoms include a high body mass index (BMI) and excessive body weight. It can lead to reduced quality of life and various health issues.