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Experimental diabetes drug trial halted early – what happened?

NCT ID NCT06611930

Disease control Sponsor: Cytoki Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called CK-0045 in 90 adults with type 2 diabetes and overweight or obesity. Participants received weekly injections of CK-0045 or a placebo for 16 weeks to see if it improved blood sugar after meals and reduced body weight. The trial was terminated early, so its effectiveness remains unknown.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CK-0045 (a lab-made protein that mimics interleukin-22)
What this could lead to
If it had worked, CK-0045 could have offered a new weekly injection to help control blood sugar and reduce weight in people with type 2 diabetes and obesity.
What could go wrong
The trial was terminated early, so results are not available. It was a small, early-phase study, and many such drugs fail to show benefit or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

90 people

The number who actually took part.

Started

Sep 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 18-74 years old male or female diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening * Body Mass Index (BMI) between 27.0 and 40.0 kg/m\^2 at screening * Treated with diet and exercise * HbA1c 6.5-8.5%, both inclusive, at screening for participants taking 3 antidiabetic medications or HbA1c 6.5-9.0%, both inclusive, at screening for participants taking 2 or less antidiabetic medications at stable doses for at least 3 months prior to screening Key Exclusion Criteria: * Any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure or any other clinically significant history or evidence of poorly controlled cardiovascular disorder(s) as judged by the investigator. * Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, gastric banding ), and/or device-based therapy for obesity, or have had device removal within the past 6 months. * History or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity and overweight Type 2 diabetes mellitus (T2DM)

Contacts and locations

Locations

  • CRS Clinical Reserach Services Mannheim GmbH

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Profil Institut für Stoffwechselforschung GmbH

    Neuss, D-41460, Germany

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