CK-0045 proof-of-concept study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cytoki Pharma ApS

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

16 Sep 2024 → 21 Oct 2025

Decision date (initial)

2024-09-10

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Others, Safety, Efficacy

To investigate the effects of 16 weeks of treatment with CK-0045 at two different dose levels versus placebo on glucose metabolism after a mixed meal tolerance test (MMTT) in participants with overweight / obesity and Type 2 diabetes.

Secondary objectives 5

1. To assess the effects of CK-0045 on body weight.
2. To assess the effects of CK-0045 on lipid metabolism (total cholesterol, HDL-, LDLcholesterol, triglycerides, free fatty acids (FFA), Lp(a)).
3. To assess the effects of CK-0045 on HbA1c.
4. To assess the pharmacokinetics (PK) of CK-0045.
5. To investigate safety, tolerability, and immunogenicity of CK-0045.

Conditions and MedDRA coding

Type 2 diabetes and Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female person diagnosed with type 2 diabetes mellitus.
2. Age between 18 and 74 years, both inclusive, at the time of signing the informed consent.
3. Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening.
4. Treated with diet and exercise and a maximum of three antidiabetic medications at stable doses for at least 3 months prior to screening.
5. Body Mass Index (BMI) between 27.0 and 40.0 kg/m^2 and HbA1c 6.5-8.5 for participants taking 3 antidiabetic medications or HbA1c 6.5-9.0% for participants taking 2 or less antidiabetic medications at screening

Exclusion criteria 3

1. 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.
2. 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.
3. History or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in area under the plasma glucose (PG) curve after a MMTT (AUCPG0- 4h) after 16 weeks of treatment.

Secondary endpoints 1

1. Change from baseline in body weight, total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), Lp(a), and HbA1c after 16 weeks of treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cytoki Pharma ApS

Sponsor organisation

Cytoki Pharma ApS

Address

Vandtaarnsvej 77

City

Soeborg

Postcode

2860

Country

Denmark

Scientific contact point

Organisation

Cytoki Pharma ApS

Contact name

Chief Development Officer

Public contact point

Organisation

Cytoki Pharma ApS

Contact name

Chief Development Officer

Third parties 3

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications