~219 spots leftby Jan 2026

AZD5004 for Type 2 Diabetes

(SOLSTICE Trial)

Recruiting in Palo Alto (17 mi)
+103 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AstraZeneca
Must be taking: Metformin, SGLT2 inhibitors
Must not be taking: Weight loss medications
Disqualifiers: Type 1 diabetes, Retinopathy, Pancreatitis, others
Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it allows participants who are on a stable dose of metformin or an SGLT2 inhibitor. It seems you can continue these medications if they are stable.

What makes the drug AZD5004 unique for treating type 2 diabetes?

AZD5004, also known as ECC5004, is unique because it may offer a novel approach to managing type 2 diabetes, potentially involving a different mechanism of action or administration compared to existing treatments like metformin, sulfonylureas, and thiazolidinediones. However, specific details about its uniqueness are not provided in the available research.12345

Research Team

Eligibility Criteria

This trial is for adults with type 2 diabetes who have not achieved adequate blood sugar control. Participants should be able to take oral medication and commit to the study for 26 weeks. Specific medical conditions or treatments that could interfere with the study are reasons for exclusion.

Inclusion Criteria

I am 18 years old or older.
Body mass index of ≥ 23 kg/m2
Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change)
See 2 more

Exclusion Criteria

More than one episode of severe hypoglycemia within 6 months prior to screening, or history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
I have had pancreatitis before.
I have taken weight loss medication in the past 3 months.
See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD5004 or placebo for 26 weeks to evaluate efficacy, safety, and tolerability

26 weeks
Visits at baseline, weeks 4, 12, 16, and 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • AZD5004 (Anti-diabetic agent)
Trial OverviewThe trial tests a new once-daily pill, AZD5004, against a placebo (a dummy pill) and Semaglutide, an existing diabetes medication. The goal is to see if AZD5004 is effective in controlling blood sugar levels over a period of 26 weeks.
Participant Groups
8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 6Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group II: Arm 5Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group III: Arm 4Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group IV: Arm 3Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group V: Arm 2Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group VI: Arm 1Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group VII: Arm 7Active Control1 Intervention
Participants will receive once daily dose of Semaglutide as active comparator
Group VIII: Arm 8Placebo Group1 Intervention
Participants will receive matching placebo for each AZD5004 arm

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

In a 6-month study involving 12 type 2 diabetic patients with end-stage renal disease, troglitazone treatment did not significantly improve overall glycemic control compared to control, but it did allow for a significant reduction in insulin dosage.
The study found that troglitazone was safe for patients requiring dialysis, with no observed weight changes or elevated liver enzyme levels, supporting the use of thiazolidinediones in diabetic patients with renal failure.
The metabolic effects of troglitazone in patients with diabetes and end-stage renal disease.Mohideen, P., Bornemann, M., Sugihara, J., et al.[2018]
Type 2 diabetes is primarily caused by two factors: insufficient insulin secretion and insulin resistance, with most individuals experiencing both issues for the disease to manifest.
The article reviews new and emerging pharmacological agents, including sulfonylureas and non-sulfonylureas, aimed at addressing these metabolic defects to improve diabetes management.
Novel sulfonylurea and non-sulfonylurea drugs to promote the secretion of insulin.Perfetti, R., Ahmad, A.[2019]
Dipeptidyl peptidase-IV (DPP-4) inhibitors are a newer class of oral medications for type 2 diabetes that offer moderate efficacy and a low side-effect profile, making them a good alternative when metformin causes gastrointestinal issues or when sulfonylureas lead to hypoglycemia or weight gain.
Other newer agents like meglitinide analogs and α-glucosidase inhibitors have limitations such as frequent dosing and gastrointestinal side effects, while bile-acid sequestrants and bromocriptine have lower efficacy in reducing HbA(1c) but a low risk of hypoglycemia.
A review of the efficacy and safety of oral antidiabetic drugs.Stein, SA., Lamos, EM., Davis, SN.[2022]

References

The metabolic effects of troglitazone in patients with diabetes and end-stage renal disease. [2018]
Novel sulfonylurea and non-sulfonylurea drugs to promote the secretion of insulin. [2019]
A review of the efficacy and safety of oral antidiabetic drugs. [2022]
Zucker Diabetic-Sprague Dawley (ZDSD) rat: Type 2 diabetes translational research model. [2022]
In vivo prevention of hyperglycemia also prevents glucotoxic effects on PDX-1 and insulin gene expression. [2022]