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

January 12, 2026 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
406

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 2V6
        • Research Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Research Site
      • Burlington, Ontario, Canada, L7M 4Y1
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
    • Quebec
      • Lévis, Quebec, Canada, G6V 6E2
        • Research Site
  • Germany
      • Falkensee, Germany, 14612
        • Research Site
      • Hamburg, Germany, 22607
        • Research Site
      • Münster, Germany, 48145
        • Research Site
      • Oldenburg, Germany, 23758
        • Research Site
      • Sankt Ingbert, Germany, 66386
        • Research Site
      • Wangen, Germany, 88239
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1036
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Szeged, Hungary, 6725
        • Research Site
  • Japan
      • Chūōku, Japan, 103-0027
        • Research Site
      • Chūōku, Japan, 104-0031
        • Research Site
      • Matsuyama, Japan, 7900034
        • Research Site
      • Shinjuku-ku, Japan, 160-0008
        • Research Site
  • Poland
      • Bialystok, Poland, 15-435
        • Research Site
      • Krakow, Poland, 31-261
        • Research Site
      • Krakow, Poland, 31-156
        • Research Site
      • Lodz, Poland, 90-338
        • Research Site
      • Lublin, Poland, 20-718
        • Research Site
      • Poznan, Poland, 60-589
        • Research Site
      • Poznan, Poland, 61-655
        • Research Site
      • Tarnów, Poland, 33-100
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • Research Site
      • Prešov, Slovakia, 080 01
        • Research Site
      • Rožňava, Slovakia, 048 01
        • Research Site
      • Sabinov, Slovakia, 083 01
        • Research Site
      • Trebišov, Slovakia, 07501
        • Research Site
  • Spain
      • A Coruña, Spain, 15006
        • Research Site
      • Barcelona, Spain, 8035
        • Research Site
      • Madrid, Spain, 28006
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Seville, Spain, 41003
        • Research Site
      • Seville, Spain, 41010
        • Research Site
      • Seville, Spain, 41950
        • Research Site
  • United Kingdom
      • Blackpool, United Kingdom, FY3 7EN
        • Research Site
      • Bristol, United Kingdom, BS34 6BQ
        • Research Site
      • Chesterfield, United Kingdom, S40 4AA
        • Research Site
      • Corby, United Kingdom, NN17 2UR
        • Research Site
      • Dundee, United Kingdom, DD1 9SY
        • Research Site
      • Rotherham, United Kingdom, S65 1DA
        • Research Site
      • Yate, United Kingdom, BS37 4AX
        • Research Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Research Site
      • Sheffield, Alabama, United States, 35660
        • Research Site
      • Vestavia Hills, Alabama, United States, 35216
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Long Beach, California, United States, 90815
        • Research Site
      • Los Angeles, California, United States, 90017
        • Research Site
      • Newport Beach, California, United States, 92660
        • Research Site
      • Sacramento, California, United States, 95821
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Lake City, Florida, United States, 32055
        • Research Site
      • Largo, Florida, United States, 33777
        • Research Site
      • Ocoee, Florida, United States, 34761
        • Research Site
      • Orlando, Florida, United States, 32804
        • Research Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Research Site
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Research Site
    • Maryland
      • Potomac, Maryland, United States, 20854
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Research Site
      • Roslindale, Massachusetts, United States, 02131
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • Research Site
    • New York
      • Binghamton, New York, United States, 13905
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Research Site
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • Rocky Mount, North Carolina, United States, 27804
        • Research Site
      • Statesville, North Carolina, United States, 28625
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Research Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19380
        • Research Site
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Research Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Research Site
      • Dallas, Texas, United States, 75230
        • Research Site
      • El Paso, Texas, United States, 79935
        • Research Site
      • Houston, Texas, United States, 77004
        • Research Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Research Site
      • Manassas, Virginia, United States, 20110
        • Research Site
      • Norfolk, Virginia, United States, 23504
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Research Site
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Participants will receive xx mg once daily dose of AZD5004
Drug: AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Experimental: Arm 2
Participants will receive xx mg once daily dose of AZD5004
Drug: AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Experimental: Arm 3
Participants will receive xx mg once daily dose of AZD5004
Drug: AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Experimental: Arm 4
Participants will receive xx mg once daily dose of AZD5004
Drug: AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Experimental: Arm 5
Participants will receive xx mg once daily dose of AZD5004
Drug: AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Experimental: Arm 6
Participants will receive xx mg once daily dose of AZD5004
Drug: AZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
Active Comparator: Arm 7
Participants will receive once daily dose of Semaglutide as active comparator
Drug: Semaglutide
3-14 mg tablets of Semaglutide
Other Names:
  • Rybelsus
Placebo Comparator: Arm 8
Participants will receive matching placebo for each AZD5004 arm
Drug: Placebo (placebo matching AZD5004 film-coated tablet)
Placebo film-coated tablet (matching AZD5004)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on glycemic control
Baseline to Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in fasting glucose
Time Frame: Baseline to Weeks 4, 12, 16 and 26
To evaluate the effect of AZD5004 versus placebo on fasting glucose
Baseline to Weeks 4, 12, 16 and 26
Percent change in body weight
Time Frame: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on weight loss
Baseline to Week 26
Absolute change in body weight
Time Frame: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on weight loss
Baseline to Week 26
Achievement of HbA1c ≤ 6.5%
Time Frame: Week 26
To evaluate of the effect of AZD5004 versus placebo on HbA1c
Week 26
Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%
Time Frame: Week 26
To evaluate the effect of AZD5004 versus placebo on HbA1c
Week 26
Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction
Time Frame: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on weight loss
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D7261C00001
  • 2024-512562-34-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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