Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. (SOLSTICE)

AstraZeneca

Status and phase: Enrolling; Phase 2

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06579105

2024-512562-34-00 (Registry Identifier)

D7261C00001

Details and patient eligibility

About

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.

Full description

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. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.

Enrollment: 384 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Adults ≥ 18 years of age.

Diagnosed with T2DM for at least 6 months.

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.

Body mass index of ≥ 23 kg/m2.

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

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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384 participants in 8 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Participants will receive xx mg once daily dose of AZD5004

Treatment:

Drug: AZD5004

Arm 2

Experimental group

Description:

Participants will receive xx mg once daily dose of AZD5004

Treatment:

Drug: AZD5004

Arm 3

Experimental group

Description:

Participants will receive xx mg once daily dose of AZD5004

Treatment:

Drug: AZD5004

Arm 4

Experimental group

Description:

Participants will receive xx mg once daily dose of AZD5004

Treatment:

Drug: AZD5004

Arm 5

Experimental group

Description:

Participants will receive xx mg once daily dose of AZD5004

Treatment:

Drug: AZD5004

Arm 6

Experimental group

Description:

Participants will receive xx mg once daily dose of AZD5004

Treatment:

Drug: AZD5004

Arm 7

Active Comparator group

Description:

Participants will receive once daily dose of Semaglutide as active comparator

Treatment:

Drug: Semaglutide

Arm 8

Placebo Comparator group

Description:

Participants will receive matching placebo for each AZD5004 arm

Treatment:

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