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

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: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: AZD5004; Drug: Semaglutide; Drug: Placebo (placebo matching AZD5004 film-coated tablet)

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: Interventional
• Enrollment (Actual): 406
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	To evaluate the effect of AZD5004 versus placebo on glycemic control	Baseline to Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting glucose	To evaluate the effect of AZD5004 versus placebo on fasting glucose	Baseline to Weeks 4, 12, 16 and 26
Percent change in body weight	To evaluate the effect of AZD5004 versus placebo on weight loss	Baseline to Week 26
Absolute change in body weight	To evaluate the effect of AZD5004 versus placebo on weight loss	Baseline to Week 26
Achievement of HbA1c ≤ 6.5%	To evaluate of the effect of AZD5004 versus placebo on HbA1c	Week 26
Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%	To evaluate the effect of AZD5004 versus placebo on HbA1c	Week 26
Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction	To evaluate the effect of AZD5004 versus placebo on weight loss	Baseline to Week 26

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): December 19, 2025
• Study Completion (Actual): December 19, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Substandard Drugs; Pharmaceutical Preparations; semaglutide
• Other Study ID 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