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.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240411

Enrollment

Registered

2024-10-16

Start date

2024-11-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Canada, Germany, Hungary, Japan, Poland, Slovakia, Spain, United Kingdom, US

Contacts

Public ContactYuji Ageishi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026