Diabetes Mellitus, Type 2Phase 2SOLSTICENCT06579105
Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
A Phase 2 study testing AZD5004 and Semaglutide in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 97 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- AZD5004 and Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 97 sitesin 9 countries
- Study dates
- 8 Oct 2024to 19 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
97 sites in 9 countries.
97 sites in 9 countries
United States50 sites
Research Site
Abilene, Texas, 79606
Research Site
Albuquerque, New Mexico, 87107
Research Site
Beachwood, Ohio, 44122
Research Site
Binghamton, New York, 13905
Research Site
Boston, Massachusetts, 02115
Research Site
Bristol, Tennessee, 37620
Research Site
Charlottesville, Virginia, 22911
Research Site
Cincinnati, Ohio, 45219
Research Site
Dallas, Texas, 75230
Research Site
Decatur, Georgia, 30030
Research Site
Durham, North Carolina, 27701
Research Site
El Paso, Texas, 79935
Research Site
Fargo, North Dakota, 58104
Research Site
Farmington Hills, Michigan, 48334
Research Site
Gaffney, South Carolina, 29340
Research Site
Greensboro, North Carolina, 27408
Research Site
Gulfport, Mississippi, 39503
Research Site
Houston, Texas, 77004
Research Site
Kansas City, Missouri, 64111
Research Site
Kingwood, West Virginia, 26537
Research Site
Lake City, Florida, 32055
Research Site
Largo, Florida, 33777
Research Site
Las Vegas, Nevada, 89109
Research Site
Little Rock, Arkansas, 72205
Research Site
Lombard, Illinois, 60148
Research Site
Long Beach, California, 90815
Research Site
Los Angeles, California, 90017
Research Site
Manassas, Virginia, 20110
Research Site
Medford, Oregon, 97504
Research Site
Mobile, Alabama, 36608
Research Site
Newport Beach, California, 92660
Research Site
Norfolk, Virginia, 23504
Research Site
Ocoee, Florida, 34761
Research Site
Omaha, Nebraska, 68134
Research Site
Orlando, Florida, 32804
Research Site
Potomac, Maryland, 20854
Research Site
Rocky Mount, North Carolina, 27804
Research Site
Roslindale, Massachusetts, 02131
Research Site
Sacramento, California, 95821
Research Site
Savannah, Georgia, 31406
Research Site
Seattle, Washington, 98105
Research Site
Sheffield, Alabama, 35660
Research Site
Statesville, North Carolina, 28625
Research Site
Tucson, Arizona, 85710
Research Site
Vestavia Hills, Alabama, 35216
Research Site
Waterbury, Connecticut, 06708
Research Site
West Chester, Pennsylvania, 19380
Research Site
West Jordan, Utah, 84088
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103
Poland8 sites
Research Site
Bialystok, 15-435
Research Site
Krakow, 31-156
Research Site
Krakow, 31-261
Research Site
Lodz, 90-338
Research Site
Lublin, 20-718
Research Site
Poznan, 60-589
Research Site
Poznan, 61-655
Research Site
Tarnów, 33-100
Spain7 sites
Research Site
A Coruña, 15006
Research Site
Barcelona, 8035
Research Site
Madrid, 28006
Research Site
Málaga, 29010
Research Site
Seville, 41003
Research Site
Seville, 41010
Research Site
Seville, 41950
United Kingdom7 sites
Research Site
Blackpool, FY3 7EN
Research Site
Bristol, BS34 6BQ
Research Site
Chesterfield, S40 4AA
Research Site
Corby, NN17 2UR
Research Site
Dundee, DD1 9SY
Research Site
Rotherham, S65 1DA
Research Site
Yate, BS37 4AX
Canada6 sites
Research Site
Brampton, Ontario, L6T 0G1
Research Site
Burlington, Ontario, L7M 4Y1
Research Site
Lévis, Quebec, G6V 6E2
Research Site
Sarnia, Ontario, N7T 4X3
Research Site
Surrey, British Columbia, V3T 2V6
Research Site
Toronto, Ontario, M9V 4B4
Germany6 sites
Research Site
Falkensee, 14612
Research Site
Hamburg, 22607
Research Site
Münster, 48145
Research Site
Oldenburg, 23758
Research Site
Sankt Ingbert, 66386
Research Site
Wangen, 88239
Slovakia5 sites
Research Site
Bratislava, 831 03
Research Site
Prešov, 080 01
Research Site
Rožňava, 048 01
Research Site
Sabinov, 083 01
Research Site
Trebišov, 07501
Hungary4 sites
Research Site
Budapest, 1036
Research Site
Budapest, 1083
Research Site
Debrecen, 4032
Research Site
Szeged, 6725
Japan4 sites
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Matsuyama, 7900034
Research Site
Shinjuku-ku, 160-0008
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo (placebo matching AZD5004 film-coated tablet), AZD5004, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (placebo matching AZD5004 film-coated tablet)Drug
Placebo film-coated tablet (matching AZD5004)
AZD5004Drug
AZD5004 film-coated tablet, once daily during 26 weeks
SemaglutideDrug
Also called Rybelsus
3-14 mg tablets of Semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive xx mg once daily dose of AZD5004 Receives: Drug: AZD5004 |
| Arm 2 | Experimental | Participants will receive xx mg once daily dose of AZD5004 Receives: Drug: AZD5004 |
| Arm 3 | Experimental | Participants will receive xx mg once daily dose of AZD5004 Receives: Drug: AZD5004 |
| Arm 4 | Experimental | Participants will receive xx mg once daily dose of AZD5004 Receives: Drug: AZD5004 |
| Arm 5 | Experimental | Participants will receive xx mg once daily dose of AZD5004 Receives: Drug: AZD5004 |
| Arm 6 | Experimental | Participants will receive xx mg once daily dose of AZD5004 Receives: Drug: AZD5004 |
| Arm 7 | Active comparator | Participants will receive once daily dose of Semaglutide as active comparator Receives: Drug: Semaglutide |
| Arm 8 | Placebo comparator | Participants will receive matching placebo for each AZD5004 arm Receives: Drug: Placebo (placebo matching AZD5004 film-coated tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
To evaluate the effect of AZD5004 versus placebo on glycemic control
Measured: Baseline to Week 26
Secondary outcomes (6)
Change in fasting glucose
To evaluate the effect of AZD5004 versus placebo on fasting glucose
Measured: Baseline to Weeks 4, 12, 16 and 26
Achievement of HbA1c ≤ 6.5%
To evaluate of the effect of AZD5004 versus placebo on HbA1c
Measured: Week 26
Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%
To evaluate the effect of AZD5004 versus placebo on HbA1c
Measured: Week 26
Percent change in body weight
To evaluate the effect of AZD5004 versus placebo on weight loss
Measured: Baseline to Week 26
Absolute change in body weight
To evaluate the effect of AZD5004 versus placebo on weight loss
Measured: Baseline to Week 26
Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction
To evaluate the effect of AZD5004 versus placebo on weight loss
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start8 Oct 2024
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579105
- Sponsor's protocol ID
- D7261C00001
- Other IDs
- 2024-512562-34-00
- Acronym
- SOLSTICE
- Status last verified
- Jan 2026
- First submitted
- 28 Aug 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Aroda VR, Davies MJ, Maaske J, Millegard M, Juan VL, Aberle J, Ciudin A, McCrimmon RJ, Eklund O, Shih JL, Sjostrand M, Zarzuela D, Rosenstock J. Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2515-2527. doi: 10.1016/S0140-6736(26)00802-0. Epub 2026 Jun 8.
PubMed 42259343
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06579105
- Acronym / sponsor ID
- SOLSTICE / D7261C00001
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AZD5004Participants will receive xx mg once daily dose of AZD5004 |
| Arm 2 | Experimental | Drug: AZD5004Participants will receive xx mg once daily dose of AZD5004 |
| Arm 3 | Experimental | Drug: AZD5004Participants will receive xx mg once daily dose of AZD5004 |
| Arm 4 | Experimental | Drug: AZD5004Participants will receive xx mg once daily dose of AZD5004 |
| Arm 5 | Experimental | Drug: AZD5004Participants will receive xx mg once daily dose of AZD5004 |
| Arm 6 | Experimental | Drug: AZD5004Participants will receive xx mg once daily dose of AZD5004 |
| Arm 7 | Active comparator | Drug: SemaglutideParticipants will receive once daily dose of Semaglutide as active comparator |
| Arm 8 | Placebo comparator | Drug: Placebo (placebo matching AZD5004 film-coated tablet)Participants will receive matching placebo for each AZD5004 arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (placebo matching AZD5004 film-coated tablet)Placebo film-coated tablet (matching AZD5004) | Drug | Arm 8 |
| AZD5004AZD5004 film-coated tablet, once daily during 26 weeks | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| SemaglutideAlso: Rybelsus3-14 mg tablets of Semaglutide | Drug | Arm 7 |
Primary outcome
Change in HbA1c
Time frame: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on glycemic control
6 secondary outcomes
Change in fasting glucose
Time frame: Baseline to Weeks 4, 12, 16 and 26
Achievement of HbA1c ≤ 6.5%
Time frame: Week 26
Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%
Time frame: Week 26
Percent change in body weight
Time frame: Baseline to Week 26
Absolute change in body weight
Time frame: Baseline to Week 26
Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction
Time frame: Baseline to Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 42259343Aroda VR, Davies MJ, Maaske J, Millegard M, Juan VL, Aberle J, Ciudin A, McCrimmon RJ, Eklund O, Shih JL, Sjostrand M, Zarzuela D, Rosenstock J. Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial. Lancet. 2026 Jun 20;407(10547):2515-2527. doi: 10.1016/S0140-6736(26)00802-0. Epub 2026 Jun 8.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
97 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD5004 and Semaglutide in people with Diabetes Mellitus, Type 2, run by AstraZeneca at 97 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Poland, Spain, United Kingdom, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Baseline to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.