Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled proof-of-concept parallel group clinical trial to investigate the efficacy, safety and tolerability of weekly subcutaneous (SC) dosing of CK-0045 in participants with overweight / obesity and Type 2 diabetes

This research study is looking into a new medicine called CK-0045. It's designed for adults who have both type 2 diabetes and are overweight. The main goal is to find out if taking CK-0045 as a weekly injection under the skin can help to better manage blood sugar levels over 16 weeks. Researchers will compare it to a dummy medicine (placebo) to see if it's effective, safe, and well-tolerated. They will also look at how it affects body weight and other important measures like cholesterol. This is an early-stage study to understand more about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cytoki Pharma ApS

Enrolment target

Start

10 Sep 2024

Type 2 diabetes and Obesity

What is this study about?

This study is investigating a new medication, called CK-0045, which is given as an injection under the skin once a week. It's for adults who live with both type 2 diabetes and are also overweight. The main purpose is to see if this new medicine can help improve how the body handles sugar, specifically by looking at blood sugar levels after a special drink over 16 weeks.

Type 2 diabetes means your body doesn't use insulin properly, leading to high blood sugar. Being overweight often goes hand-in-hand with this condition. The researchers want to understand if CK-0045 can make a difference in controlling blood sugar and possibly help with weight management, which could lead to better overall health.

Because this is an early-stage study (called Phase II), it's about exploring if the medicine works and if it's safe for people to take. It helps us learn more about potential new ways to care for people with these conditions. Participants will receive either the study medicine or a dummy medicine, without knowing which one they have, so we can get clear results.

Key takeaways

Tests a new weekly injection (CK-0045) for type 2 diabetes and overweight.
Compares the new medicine to a dummy medicine (placebo).
Aims to improve blood sugar control and other health measures.
Study lasts for 16 weeks of treatment.
Open to adults aged 18 and over with both conditions.
Results will help understand if this could be a future treatment option.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, who have already been diagnosed with both type 2 diabetes and are considered overweight. Both men and women can take part.

You would need to meet specific health criteria related to your diabetes and weight. For example, your current diabetes treatment and any other health conditions you have would be carefully reviewed.

It's important to discuss your full medical history with the study team to see if this trial is the right fit for you. Not everyone with these conditions will be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Type 2 diabetes?
Are you also considered overweight?
Are you able to attend regular clinic appointments?
Are you willing to have weekly injections and blood tests?
Are you happy to receive either the study drug or a placebo?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be involved for 16 weeks of treatment, plus some screening and follow-up visits. You would receive either the study medicine, CK-0045, or a placebo (a dummy medicine with no active ingredients). This would be given as a weekly injection under the skin.

During your time in the study, you would have regular visits to the clinic. These visits would include check-ups, blood tests to measure your blood sugar, cholesterol, and other health markers, and weight measurements. At the start and end of the 16 weeks, you'd have a specific test involving a drink to see how your body handles sugar. All tests and medicines are provided as part of the study. You'd also need to notify the study team of any new health concerns.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving free medical care related to the study conditions and access to a new treatment that isn't yet widely available. However, there's no guarantee the medicine will help you, and you might receive a placebo. Potential risks could include side effects from the study medicine, although these would be carefully monitored. Blood tests and injections can cause minor discomfort or bruising. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is CK-0045?

It's a new medicine being tested to see if it can help people with type 2 diabetes and overweight manage their health better.

How is the medicine given?

It's given as an injection under the skin once a week.

How long does the study last?

The main part of the study with the medicine lasts for 16 weeks.

Will I definitely get the new medicine?

You might get the new medicine or a dummy medicine (placebo). Neither you nor the study team will know which one you're receiving.

What is the main thing the study is looking for?

The main goal is to see if the medicine helps control blood sugar levels after a meal over 16 weeks.