Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.
NCT Number: NCT06579105
Acronym: SOLSTICE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo (placebo matching AZD5004 film-coated tablet)|DRUG: AZD5004|DRUG: Semaglutide
Sponsor: AstraZeneca
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 384
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-08
Completion Date: 2025-12-23
Locations: Research Site, Birmingham, Alabama, 35216, United States|Research Site, Mobile, Alabama, 36608, United States|Research Site, Sheffield, Alabama, 35660, United States|Research Site, Little Rock, Arkansas, 72205, United States|Research Site, Lincoln, California, 95648, United States|Research Site, Waterbury, Connecticut, 06708, United States|Research Site, Edgewater, Florida, 32132, United States|Research Site, Lake City, Florida, 32055, United States|Research Site, Ocoee, Florida, 34761, United States|Research Site, Orlando, Florida, 32804, United States|Research Site, Seminole, Florida, 33777, United States|Research Site, Atlanta, Georgia, 30342, United States|Research Site, Savannah, Georgia, 31406, United States|Research Site, Lombard, Illinois, 60148, United States|Research Site, Slidell, Louisiana, 70458, United States|Research Site, Boston, Massachusetts, 02115, United States|Research Site, Roslindale, Massachusetts, 02131, United States|Research Site, Farmington Hills, Michigan, 48334, United States|Research Site, Gulfport, Mississippi, 39503, United States|Research Site, Bridgeton, Missouri, 63044, United States|Research Site, Omaha, Nebraska, 68134, United States|Research Site, Las Vegas, Nevada, 89109, United States|Research Site, Albuquerque, New Mexico, 87107, United States|Research Site, Binghamton, New York, 13905, United States|Research Site, Durham, North Carolina, 27701, United States|Research Site, Greensboro, North Carolina, 27408, United States|Research Site, Rocky Mount, North Carolina, 27804, United States|Research Site, Statesville, North Carolina, 28625, United States|Research Site, Wilmington, North Carolina, 28401, United States|Research Site, Winston-Salem, North Carolina, 27103, United States|Research Site, Fargo, North Dakota, 58104, United States|Research Site, Beachwood, Ohio, 44122, United States|Research Site, Cincinnati, Ohio, 45219, United States|Research Site, Medford, Oregon, 97504, United States|Research Site, Charleston, South Carolina, 29414, United States|Research Site, Gaffney, South Carolina, 29340, United States|Research Site, Bristol, Tennessee, 37620, United States|Research Site, Dallas, Texas, 75230, United States|Research Site, Houston, Texas, 77004, United States|Research Site, West Jordan, Utah, 84088, United States|Research Site, Charlottesville, Virginia, 22911, United States|Research Site, Hampton, Virginia, 23666, United States|Research Site, Norfolk, Virginia, 23504, United States|Research Site, Seattle, Washington, 98105, United States|Research Site, Spokane, Washington, 99218, United States|Research Site, Kingwood, West Virginia, 26537, United States|Research Site, Surrey, British Columbia, V3T 2V6, Canada|Research Site, Burlington, Ontario, L7M 4Y1, Canada|Research Site, Sarnia, Ontario, N7T 4X3, Canada|Research Site, Toronto, Ontario, M9V 4B4, Canada|Research Site, Levis, Quebec, G6V 6E2, Canada|Research Site, Essen, 45136, Germany|Research Site, Falkensee, 14612, Germany|Research Site, Hamburg, 22607, Germany|Research Site, Mannheim, 68167, Germany|Research Site, Münster, 48145, Germany|Research Site, Oldenburg, 23758, Germany|Research Site, Sankt Ingbert, 66386, Germany|Research Site, Wangen, 88239, Germany|Research Site, Budapest, 1036, Hungary|Research Site, Budapest, 1083, Hungary|Research Site, Debrecen, 4032, Hungary|Research Site, Szeged, 6725, Hungary|Research Site, Szolnok, 5000, Hungary|Research Site, Chuo-ku, 104-0031, Japan|Research Site, Chuo-ku, 1040031, Japan|Research Site, Mstsuyama-shi, 8100001, Japan|Research Site, Shinjuku-ku, 160-0008, Japan|Research Site, Suita-shi, 565-0853, Japan|Research Site, Białystok, 15-435, Poland|Research Site, Katowice, 40-772, Poland|Research Site, Krakow, 31-261, Poland|Research Site, Lublin, 20-718, Poland|Research Site, Poznań, 60-589, Poland|Research Site, Poznań, 61-655, Poland|Research Site, Tarnów, 33-100, Poland|Research Site, Bratislava, 831 03, Slovakia|Research Site, Presov, 080 01, Slovakia|Research Site, Roznava, 048 01, Slovakia|Research Site, Sabinov, 083 01, Slovakia|Research Site, Trebišov, 07501, Slovakia|Research Site, Barcelona, 8035, Spain|Research Site, La Coruna, 15006, Spain|Research Site, Madrid, 28006, Spain|Research Site, Málaga, 29010, Spain|Research Site, Sevilla, 41003, Spain|Research Site, Sevilla, 41010, Spain|Research Site, Sevilla, 41950, Spain|Research Site, Blackpool, FY3 7EN, United Kingdom|Research Site, Bristol, BS34 6BQ, United Kingdom|Research Site, Chesterfield, S40 4AA, United Kingdom|Research Site, Corby, NN17 2UR, United Kingdom|Research Site, Dundee, DD1 9SY, United Kingdom

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.

Primary Outcome Measures: Change in HbA1c, To evaluate the effect of AZD5004 versus placebo on glycemic control, Baseline to Week 26
Secondary Outcome Measures: Change in fasting glucose, To evaluate the effect of AZD5004 versus placebo on fasting glucose, Baseline to Weeks 4, 12, 16 and 26|Proportion of participants achieving HbA1c ≤ 6.5% and < 7.0%, To evaluate of the effect of AZD5004 versus placebo on HbA1c, Week 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|Proportion of participants with ≥ 5%, ≥ 10% and ≥ 15% weight reduction, To evaluate the effect of AZD5004 versus placebo on weight loss, Week 26