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This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. (SOLSTICE)

A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults With Type 2 Diabetes Mellitus.

Ageishi Yuji

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Ageishi Yuji

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3533

RD-clinical-information-Japan@astrazeneca.com

Complete

Nov. 22, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Adults 18 years of age or more.

Diagnosed with T2DM for at least 6 months.

HbA1c 7.0% or more and 10.5% or less 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.

Body mass index of 23 kg/m2 or more.

Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).

Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.

History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.

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.

Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.

Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).

History of acute or chronic pancreatitis.

Both

Diabetes Mellitus, Type 2

Drug: Placebo (placebo matching AZD5004 film-coated tablet)
Drug: AZD5004
Drug: Semaglutide

Change in HbA1c at baseline to Week 26
(Mesure Description: To evaluate the effect of AZD5004 versus placebo on glycemic control)

+81-3-3243-0138

Oct. 11, 2024

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved..

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