> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-safety-and-tolerability-of-once-daily-oral-2d13f533-2ba5-4557-9312-cc274ff7b280 > Record changed: 2026-10-13 # Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. NCT06579105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) Participants 406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) Start date 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) Number of sites 97 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Acronym** SOLSTICE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Short title** Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Dates **Completion date** 2025-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **First posted** 2024-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Registry last updated** 2026-01-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Primary completion date** 2025-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Start date** 2024-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Size and sites **Actual participants** 406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Participants** 406 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Number of sites** 97 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Identifiers **Registry ID** NCT06579105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **ClinicalTrials.gov ID** NCT06579105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masking description** Masking (blinding) applies to patients and investigators involved in AZD5004 and placebo arms, however not in active comparator arm. **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Outcomes ### Primary outcomes 1. Change in HbA1c Timeframe: Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on glycemic control ### Secondary outcomes 1. Change in fasting glucose Timeframe: Baseline to Weeks 4, 12, 16 and 26 To evaluate the effect of AZD5004 versus placebo on fasting glucose 2. Achievement of HbA1c ≤ 6.5% Timeframe: Week 26 To evaluate of the effect of AZD5004 versus placebo on HbA1c 3. Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0% Timeframe: Week 26 To evaluate the effect of AZD5004 versus placebo on HbA1c 4. Percent change in body weight Timeframe: Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on weight loss 5. Absolute change in body weight Timeframe: Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on weight loss 6. Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction Timeframe: Baseline to Week 26 To evaluate the effect of AZD5004 versus placebo on weight loss Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Sites - Research SiteMobile, United States - Research SiteSheffield, United States - Research SiteVestavia Hills, United States - Research SiteTucson, United States - Research SiteLittle Rock, United States - Research SiteLong Beach, United States - Research SiteLos Angeles, United States - Research SiteNewport Beach, United States - Research SiteSacramento, United States - Research SiteWaterbury, United States - Research SiteLake City, United States - Research SiteLargo, United States - Research SiteOcoee, United States - Research SiteOrlando, United States - Research SiteDecatur, United States - Research SiteSavannah, United States - Research SiteLombard, United States - Research SitePotomac, United States - Research SiteBoston, United States - Research SiteRoslindale, United States - Research SiteFarmington Hills, United States - Research SiteGulfport, United States - Research SiteKansas City, United States - Research SiteOmaha, United States - Research SiteLas Vegas, United States And 72 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## References - PubMed 42259343 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42259343/) Related publication ### Other registry identifiers - 2024-512562-34-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06579105) ## Related records ### Drugs (1) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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