Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults with Type 2 Diabetes Mellitus

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

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

24 Feb 2025 → 19 Dec 2025

Decision date (initial)

2024-11-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Dose response, Safety

To evaluate the effect of AZD5004 versus placebo on glycemic control.

Secondary objectives 3

1. To evaluate the effect of AZD5004 versus placebo on fasting glucose.
2. To evaluate the effect of AZD5004 versus placebo on HbA1c.
3. To evaluate the effect of AZD5004 versus placebo on weight loss.

Conditions and MedDRA coding

Type 2 Diabetes Mellitus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adults ≥ 18 years of age
2. Diagnosed with T2DM for at least 6 months
3. HbA1c ≥7 .0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening
4. Body mass index of ≥ 23 kg/m2
5. Stable self-reported body weight for 3 months prior to randomization (≥ 5% body weight change)
6. Capable of giving signed informed consent and complying with study requirements and restrictions listed in the ICF and protocol

Exclusion criteria 6

1. Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.
2. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.
3. Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Received medication for weight loss within the last 3 months prior to screening.
4. Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.
5. History of acute or chronic pancreatitis.
6. Cardiac arrhythmias or ECG morphology abnormalities, as considered by the investigator, that may interfere with interpretation of the QT interval corrected for heart rate (QTc) interval changes, including ST wave morphology.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in HbA1c from baseline to 26 weeks.

Secondary endpoints 6

1. Change in fasting glucose from baseline to 4, 12, 16, and 26 weeks
2. Achieved HbA1c ≤ 6.5% at 26 weeks
3. Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0% at 26 weeks
4. Percent change in body weight from baseline to 26 weeks
5. Absolute change in body weight (kg) from baseline to 26 weeks
6. Achievement of ≥ 5%, ≥ 10% and ≥ 15% weight reduction from baseline at Week 26

Investigational products

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

Test 3

Comparator 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Centre

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Centre

Locations

5 EU/EEA countries · 35 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

Documents 43 files

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

Application history

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