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SOLSTICE
CompletedPhase 2Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
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.
Lead sponsor
Assets
AZD5004 / ECC5004 / Semaglutide
Listed sites
97
Recruiting sites
—
Enrollment
406
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥23•HbA1c 7-10.5%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (7)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsPercent change in body weight
Time frame:Baseline to Week 26
Body weight, % change
percent change from baseline, improvement
Absolute change in body weight
Time frame:Baseline to Week 26
Body weight, absolute change (kg)
change from baseline, improvement
Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction
Time frame:Baseline to Week 26
≥15% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
4 endpointsChange in HbA1c
Time frame:Baseline to Week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in fasting glucose
Time frame:Baseline to Weeks 4, 12, 16 and 26
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Achievement of HbA1c ≤ 6.5%
Time frame:Week 26
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%
Time frame:Week 26
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID42259343via clinicaltrials gov reference derived
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.