Heart Failure With Preserved Ejection Fraction (HFpEF)Phase 3Elevate-HFNCT07761117
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
A Phase 3 study testing Elecoglipron in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF), run by AstraZeneca at 679 sites in 32 countries.
Trial summary
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
- What is being tested?
- Elecoglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,950 participants
- Where
- 679 sitesin 32 countries
- Study dates
- 24 Aug 2026to 3 Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Left ventricular ejection fraction (LVEF) of > 40% within 12 months prior to screening.
- Structural heart disease evidence.
- HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
Who cannot join
- BMI <25 kg/m² at screening.
- Diabetes exclusions:
- History of type 1 diabetes.
- HbA1c ≥10% at screening.
- Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
- more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition.
Show all 16Show fewer
- Renal exclusions:
- On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
- Cardiovascular exclusions:
- Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization.
- Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
- GI exclusions:
- Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery.
- History of acute or chronic pancreatitis.
- Endocrine exclusions:
- History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
Trial locations and contacts
679 sites in 32 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
679 sites in 32 countries
United States120 sites, 109 recruiting
- Not yet recruiting
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Anchorage, Alaska, 99508
- Not yet recruiting
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Annapolis, Maryland, 21401
- Not yet recruiting
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Arlington, Virginia, 22205
- Not yet recruiting
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Atlanta, Georgia, 30303
- Not yet recruiting
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Baltimore, Maryland, 21229
- Withdrawn
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Bethlehem, Pennsylvania, 18015
- Not yet recruiting
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Beverly Hills, California, 90211
- Not yet recruiting
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Bossier City, Louisiana, 71111
- Not yet recruiting
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Boston, Massachusetts, 02114
- Not yet recruiting
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Boston, Massachusetts, 02118
- Withdrawn
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Bradenton, Florida, 34209
- Not yet recruiting
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Bridgeton, Missouri, 63044
- Not yet recruiting
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Bridgewater, New Jersey, 08807
- Recruiting
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Brooklyn, New York, 11220
- Not yet recruiting
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Buffalo, New York, 14215
- Withdrawn
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Burlington, Vermont, 05401
- Withdrawn
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Champaign, Illinois, 61822
- Not yet recruiting
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Chapel Hill, North Carolina, 27514
- Not yet recruiting
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Chicago, Illinois, 60640
- Not yet recruiting
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Colorado Springs, Colorado, 80909
- Not yet recruiting
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Columbus, Georgia, 31904
- Not yet recruiting
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Columbus, Ohio, 43215
- Withdrawn
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Columbus, Ohio, 43228
- Not yet recruiting
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Covington, Louisiana, 70433
- Not yet recruiting
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Dallas, Texas, 75216
- Not yet recruiting
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Dayton, Ohio, 45435
- Not yet recruiting
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DeSoto, Texas, 75115
- Not yet recruiting
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Durham, North Carolina, 27710
- Not yet recruiting
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East Providence, Rhode Island, 02914
- Not yet recruiting
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El Paso, Texas, 79905
- Recruiting
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Fairhope, Alabama, 36532
- Not yet recruiting
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Fargo, North Dakota, 58104
- Recruiting
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Flint, Michigan, 48503
- Not yet recruiting
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Gilbert, Arizona, 85295
- Not yet recruiting
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Grand Forks, North Dakota, 58201
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Greensboro, North Carolina, 27401
- Not yet recruiting
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Gurnee, Illinois, 60031
- Not yet recruiting
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Hallandale, Florida, 33009
- Not yet recruiting
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Houston, Texas, 77025
- Not yet recruiting
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Houston, Texas, 77082
- Recruiting
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Humble, Texas, 77338
- Not yet recruiting
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Huntington Beach, California, 92647
- Not yet recruiting
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Huntington Park, California, 90255
- Not yet recruiting
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Indianapolis, Indiana, 46254
- Not yet recruiting
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Jacksonville, Florida, 32209
- Withdrawn
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Kansas City, Missouri, 64111
- Not yet recruiting
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Kansas City, Missouri, 64112
- Not yet recruiting
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Kingwood, West Virginia, 26537
- Not yet recruiting
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Lafayette, Louisiana, 70503
- Not yet recruiting
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Lakeland, Florida, 33813
- Not yet recruiting
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Lanham, Maryland, 20706
- Not yet recruiting
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Leavenworth, Kansas, 66048
- Not yet recruiting
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Lincoln, Nebraska, 68510
- Not yet recruiting
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Loma Linda, California, 92354
- Recruiting
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Lomita, California, 90717
- Not yet recruiting
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Mather, California, 95655
- Not yet recruiting
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Maumee, Ohio, 43537
- Not yet recruiting
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Media, Pennsylvania, 19063
- Not yet recruiting
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Melrose Park, Illinois, 60160
- Not yet recruiting
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Miami, Florida, 33125
- Not yet recruiting
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Miami, Florida, 33144
- Not yet recruiting
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Miami, Florida, 33176
- Withdrawn
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Miami Lakes, Florida, 33014
- Recruiting
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Miami Lakes, Florida, 33016
- Not yet recruiting
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Millville, New Jersey, 08332
- Not yet recruiting
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Moline, Illinois, 61265
- Not yet recruiting
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Morgantown, West Virginia, 26505
- Not yet recruiting
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New Bedford, Massachusetts, 02740
- Not yet recruiting
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New Haven, Connecticut, 06519
- Not yet recruiting
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New Orleans, Louisiana, 70121
- Not yet recruiting
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New York, New York, 10001
- Not yet recruiting
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New York, New York, 10019
- Not yet recruiting
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Niles, Illinois, 60714
- Not yet recruiting
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Northridge, California, 91324
- Not yet recruiting
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Ocala, Florida, 34470
- Withdrawn
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Ocoee, Florida, 34761
- Not yet recruiting
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Oklahoma City, Oklahoma, 73134
- Not yet recruiting
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Owensboro, Kentucky, 42301
- Not yet recruiting
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Oxon Hill, Maryland, 20745
- Not yet recruiting
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Palmetto Bay, Florida, 33157
- Not yet recruiting
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Palo Alto, California, 94304
- Not yet recruiting
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Philadelphia, Pennsylvania, 19104
- Not yet recruiting
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Philadelphia, Pennsylvania, 19107
- Withdrawn
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Plano, Texas, 75093
- Not yet recruiting
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Rapid City, South Dakota, 57701
- Not yet recruiting
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Redding, California, 96001
- Recruiting
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Redmond, Washington, 98052
- Not yet recruiting
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Riverview, Florida, 33578
- Not yet recruiting
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Rockford, Illinois, 61107
- Not yet recruiting
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Rosedale, New York, 11422
- Not yet recruiting
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San Antonio, Texas, 78231
- Not yet recruiting
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San Antonio, Texas, 78257
- Not yet recruiting
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San Diego, California, 92117
- Not yet recruiting
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Schaumburg, Illinois, 60173
- Not yet recruiting
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Sewell, New Jersey, 08080
- Not yet recruiting
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Shreveport, Louisiana, 71105
- Not yet recruiting
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Smithfield, Pennsylvania, 15478
- Not yet recruiting
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Southfield, Michigan, 48075
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Southfield, Michigan, 48076
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Spartanburg, South Carolina, 29303
- Not yet recruiting
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Statesville, North Carolina, 28677
- Not yet recruiting
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Sun City, Arizona, 85351
- Not yet recruiting
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Tampa, Florida, 33617
- Withdrawn
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Tarzana, California, 91356
- Not yet recruiting
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The Bronx, New York, 10451
- Recruiting
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The Bronx, New York, 10455
- Recruiting
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Tomball, Texas, 77375
- Not yet recruiting
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Trenton, New Jersey, 08690
- Not yet recruiting
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Troy, Michigan, 48098
- Not yet recruiting
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Tucker, Georgia, 30084
- Not yet recruiting
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Tyler, Texas, 75701
- Not yet recruiting
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Victoria, Texas, 77901
- Not yet recruiting
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Vineland, New Jersey, 08360
- Not yet recruiting
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Waterloo, Iowa, 50701
- Not yet recruiting
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Wichita, Kansas, 67214
- Not yet recruiting
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Wilmington, North Carolina, 28401
- Not yet recruiting
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Winfield, Illinois, 60190
- Withdrawn
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Worcester, Massachusetts, 01655
- Not yet recruiting
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Yardley, Pennsylvania, 19067
- Not yet recruiting
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Zachary, Louisiana, 70791
China88 sites, 84 recruiting
- Not yet recruiting
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Baoding, 072750
- Not yet recruiting
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Baotou
- Not yet recruiting
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Beijing, 100000
- Not yet recruiting
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Beijing, 100022
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Beijing, 100034
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Beijing, 100037
- Not yet recruiting
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Beijing, 100044
- Not yet recruiting
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Beijing, 100050
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Beijing, 100053
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Beijing, 100142
- Not yet recruiting
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Beijing, 102218
- Not yet recruiting
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Beijing
- Not yet recruiting
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Bozhou, 236000
- Not yet recruiting
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Changchun, 130021
- Not yet recruiting
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Changchun, 130033
- Not yet recruiting
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Changchun, 130041
- Withdrawn
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Changde, 415000
- Withdrawn
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Changsha, 410300
- Not yet recruiting
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Chengdu, 610031
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Chengdu, 610041
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Chengdu, 610078
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Chifeng, 024000
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Daqing, 163000
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Foshan, 528308
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Guangzhou, 510000
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Guangzhou, 510289
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Haikou, 570311
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Hefei, 230601
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Heze, 274099
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Huaian, 223300
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Huizhou, 516002
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Jiangmen, 529000
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Jinan, 250012
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Jinan, 250031
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Jining, 272006
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Lanzhou, 730000
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Linhai, 317000
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Lishui, 323000
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Luoyang, 471001
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Nanchang, 330009
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Nanjing, 2100008
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Nanjing, 210009
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Nanjing, 210011
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Nanyang, 473000
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Ningbo, 315000
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Panjin, 124009
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Pingxiang, 337055
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Qingzhou, 262550
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Sanya, 572000
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Shanghai, 200090
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Shanghai, 200135
- Not yet recruiting
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Shanghai, 201107
- Not yet recruiting
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Shanghai, 201199
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Shantou, 515041
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Shaoguan, 512027
- Not yet recruiting
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Shaoxing, 312000
- Not yet recruiting
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Shenyang, 110016
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Shenzhen, 518053
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Siping, 136000
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Suining, 629000
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Suzhou, 215004
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Suzhou, 215006
- Not yet recruiting
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Taian, 271099
- Not yet recruiting
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Tianjin, 300000
- Withdrawn
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Tianjin, 300050
- Not yet recruiting
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Ürümqi, 830001
- Not yet recruiting
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Wanzhou, 404000
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Weifang, 261000
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Wenzhou, 325000
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Wuhan, 430000
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Wuhan, 430033
- Not yet recruiting
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Wuxi, 214023
- Not yet recruiting
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Xi'an, 710061
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Xi'an, 710068
- Not yet recruiting
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Xiangtan, 411100
- Not yet recruiting
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Xuzhou, 221000
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Xuzhou, 221009
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Yancheng, 224005
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Yangzhou, 225001
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Yueyang, 414000
- Not yet recruiting
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Yuncheng, 044099
- Not yet recruiting
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Zhangjiakou, 075061
- Withdrawn
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Zhengzhou, 450002
- Not yet recruiting
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Zhengzhou, 450007
- Not yet recruiting
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Zhengzhou, 450052
- Not yet recruiting
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Zibo, 255036
- Not yet recruiting
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Zigong, 643021
- Not yet recruiting
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Zunyi, 563100
Japan61 sites, 59 recruiting
- Not yet recruiting
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Aomori, 030-8553
- Not yet recruiting
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Chikushino-shi, 818-8516
- Not yet recruiting
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Chūōku, 103-0027
- Not yet recruiting
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Fukui-shi, 910-8526
- Not yet recruiting
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Fukushima, 960-1295
- Not yet recruiting
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Higashiibaraki-gun, 311-3193
- Not yet recruiting
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Higashiohmi-shi, 527-8505
- Not yet recruiting
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Iwakuni-shi, 740-8510
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Kagoshima, 890-8760
- Not yet recruiting
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Kamakura-shi, 247-8533
- Not yet recruiting
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Kanazawa, 920-8650
- Not yet recruiting
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Kashihara-shi, 634-8522
- Recruiting
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Kasugai-shi, 486-8510
- Not yet recruiting
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Kawagoe-shi, 350-8550
- Not yet recruiting
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Kishiwada-shi, 596-0042
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Kitakyusyu-shi, 806-8501
- Not yet recruiting
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Kobe, 650-0017
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Kobe, 650-0047
- Not yet recruiting
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Kobe, 654-0081
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Kobe, 654-0155
- Not yet recruiting
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Kure-shi, 737-0193
- Not yet recruiting
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Kyoto, 604-8845
- Not yet recruiting
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Kyoto, 605-0981
- Not yet recruiting
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Maebashi, 371-8511
- Not yet recruiting
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Matsusaka-shi, 515-8557
- Not yet recruiting
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Minatoku, 108-0073
- Recruiting
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Mito, 311-4198
- Not yet recruiting
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Morioka, 020-0066
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Nagasaki, 851-0301
- Not yet recruiting
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Nagoya, 454-8502
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Nagoya, 466-8560
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Nagoya, 467-8602
- Not yet recruiting
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Ōmihachiman, 523-0082
- Withdrawn
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Osaka, 558-8558
- Not yet recruiting
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Sagamihara-shi, 252-0315
- Recruiting
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Sapporo, 003-0026
- Not yet recruiting
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Sayama-shi,, 350-1305
- Not yet recruiting
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Sendai, 981-3133
- Not yet recruiting
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Shibuya-ku, 150-0013
- Withdrawn
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Shizuoka, 420-8527
- Not yet recruiting
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Shizuoka, 420-8630
- Not yet recruiting
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Suginami City, 168-0065
- Not yet recruiting
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Suita, 565-0862
- Not yet recruiting
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Suzuka-shi, 513-8630
- Not yet recruiting
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Tachikawa-shi, 190-8531
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Takaoka-shi, 933-8555
- Not yet recruiting
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Takatsuki-shi, 569-8686
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Tokushima, 770-8503
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Toshima-ku, 171-0014
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Toyama, 930-8550
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Ueda-shi, 386-8610
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Urasoe-Shi, 901-2102
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Urayasu-shi, 279-0021
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Uruma, 904-2293
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Utsunomiya, 320-8580
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Wakayama, 640-8158
- Not yet recruiting
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Yakushi, 581-0011
- Not yet recruiting
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Yokohama, 224-8503
- Not yet recruiting
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Yokohama, 231-8682
- Not yet recruiting
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Yokohama, 236-0004
- Not yet recruiting
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Yokohama, 236-0037
Germany45 sites, 42 recruiting
- Not yet recruiting
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Bad Oldesloe, 23843
- Not yet recruiting
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Bamberg, 96049
- Withdrawn
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Berlin, 13187
- Not yet recruiting
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Berlin, 13405
- Not yet recruiting
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Berlin, 13509
- Not yet recruiting
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Bielefeld, 33604
- Not yet recruiting
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Bochum, 44789
- Not yet recruiting
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Bremen, 28277
- Not yet recruiting
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Chemnitz, 09116
- Not yet recruiting
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Cologne, 50733
- Not yet recruiting
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Dresden, 1307
- Not yet recruiting
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Elsterwerda, 04910
- Not yet recruiting
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Erlangen, 91504
- Not yet recruiting
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Essen, 45147
- Not yet recruiting
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Freiburg im Breisgau, 79106
- Not yet recruiting
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Gera, 07548
- Not yet recruiting
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Giessen, 35394
- Not yet recruiting
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Hamburg, 20099
- Not yet recruiting
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Hamburg, 21075
- Recruiting
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Hamburg, 22459
- Not yet recruiting
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Hamburg, 22559
- Not yet recruiting
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Heidelberg, 69120
- Not yet recruiting
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Homburg, 66424
- Not yet recruiting
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Jena, 07747
- Not yet recruiting
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Kaiserslautern, 67655
- Not yet recruiting
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Karlsbad, 76307
- Not yet recruiting
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Kiel, 24105
- Not yet recruiting
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Ludwigshafen, 67063
- Not yet recruiting
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Ludwigshafen am Rhein, 67071
- Recruiting
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Lüneburg, 21339
- Not yet recruiting
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Magdeburg, 39120
- Recruiting
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Mainz, 55122
- Not yet recruiting
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Mainz, 55131
- Suspended
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Markkleeberg, 04416
- Not yet recruiting
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Mühldorf A. Inn, 84453
- Not yet recruiting
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Neuruppin, 16816
- Not yet recruiting
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Nuremberg, 90402
- Not yet recruiting
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Obertshausen, 63179
- Not yet recruiting
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Paderborn, 33098
- Suspended
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Papenburg, 26871
- Not yet recruiting
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Stuttgart, 70199
- Not yet recruiting
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Trier, 54292
- Not yet recruiting
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Tübingen, 72076
- Not yet recruiting
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Ulm, 89077
- Not yet recruiting
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Weyhe, 28844
Canada21 sites, 18 recruiting
- Not yet recruiting
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Barrie, Ontario, L4M 6M2
- Not yet recruiting
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Etobicoke, Ontario, M8Z 4E4
- Not yet recruiting
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Greater Sudbury, Ontario, P3E 5J1
- Not yet recruiting
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Hamilton, Ontario, L8L 5G4
- Recruiting
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Kingston, Ontario, K7M 7E4
- Not yet recruiting
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London, Ontario, N6A 5A5
- Withdrawn
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London, Ontario, N6A 5W9
- Not yet recruiting
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Markham, Ontario, L3P 7P3
- Not yet recruiting
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Markham, Ontario, L3S 0A2
- Not yet recruiting
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Montreal, Quebec, H4A 3J1
- Recruiting
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Newmarket, Ontario, L3Y 2P6
- Recruiting
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North York, Ontario, M6B 3H7
- Withdrawn
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North York, Ontario, M9N 1W4
- Recruiting
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Oakville, Ontario, L6K 3W7
- Not yet recruiting
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Ottawa, Ontario, K1Y 4W7
- Recruiting
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Stoney Creek, Ontario, L8J 3W2
- Withdrawn
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Thunder Bay, Ontario, P7B 5N3
- Not yet recruiting
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Thunder Bay, Ontario, P7B 5N3
- Not yet recruiting
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Toronto, Ontario, M4N 3M5
- Not yet recruiting
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Toronto, Ontario, M6G 1M2
- Not yet recruiting
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Trois-Rivières, Quebec, G8Z 3R9
Czechia20 sites, 16 recruiting
- Not yet recruiting
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Benešov, 256 01
- Not yet recruiting
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Boskovice, 680 01
- Not yet recruiting
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Brno, 60200
- Not yet recruiting
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Broumov, 55001
- Withdrawn
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Česká Lípa, 470 77
- Not yet recruiting
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Český Krumlov, 381 01
- Withdrawn
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Chlumec nad Cidlinou, 503 51
- Not yet recruiting
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Hradec Králové, 500 02
- Not yet recruiting
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Hustopeče, 693 01
- Not yet recruiting
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Jaroměř, 551 01
- Withdrawn
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Kadaň, 432 01
- Not yet recruiting
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Klatovy, 339 01
- Not yet recruiting
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Liberec, 460 01
- Not yet recruiting
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Louny, 440 01
- Not yet recruiting
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Prague, 130 00
- Withdrawn
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Prague, 150 00
- Not yet recruiting
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Prague, 150 00
- Not yet recruiting
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Prague, 198 00
- Not yet recruiting
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Teplice, 415 01
- Not yet recruiting
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Vsetín, 755 01
India20 sites, 20 recruiting
- Not yet recruiting
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Belagavi, 590010
- Not yet recruiting
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Calicut, 673008
- Not yet recruiting
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Coimbatore, 641018
- Not yet recruiting
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Dehradun, 248001
- Not yet recruiting
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Delhi, 110029
- Not yet recruiting
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Delhi, 110062
- Not yet recruiting
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Hyderabad, 500035
- Not yet recruiting
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Jaipur, 302017
- Not yet recruiting
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Kanpur, 208001
- Not yet recruiting
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Kochi, 682018
- Not yet recruiting
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Kochi, 682040
- Not yet recruiting
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Kolkata, 700014
- Not yet recruiting
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Kolkata, 700020
- Not yet recruiting
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Ludhiana, 141001
- Not yet recruiting
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Meerut, 250005
- Not yet recruiting
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About this study
Official title: A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
- Being tested
- Elecoglipron, Placebo
- Keywords
- Heart failure, Elecoglipron
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElecoglipronDrug
Elecoglipron tablet
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Elecoglipron | Experimental | Elecoglipron tablet once daily Receives: Drug: Elecoglipron |
| Placebo | Active comparator | Placebo matching Elecoglipron tablet once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
Time to first event of the composite of:
- CV death
- HHF
- Urgent HF visit
Measured: Up to 42 months
Secondary outcomes (3)
To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)
Total occurrences (first and recurrent) of HF events
- HHF
- Urgent HF visit
Measured: Up to 42 months
To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.
Change from baseline to Week 52
Measured: Baseline and 52 weeks
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke
Time to first event of the composite of:
- All-cause death
- HHF
- MI
- Stroke
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start24 Aug 2026
- Primary completion3 Sep 2029 (estimated)
- Study completion3 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761117
- Sponsor's protocol ID
- D7266C00001
- Other IDs
- 2026-526304-79-00
- Acronym
- Elevate-HF
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
- ClinicalTrials.gov ID
- NCT07761117
- Acronym / sponsor ID
- Elevate-HF / D7266C00001
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
- Keywords
- Heart failure, Elecoglipron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,950 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 3 Sep 2029 (estimated)
- Study completion
- 3 Sep 2029 (estimated)
- First posted
- 12 Aug 2026 (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 III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elecoglipron | Experimental | Drug: ElecoglipronElecoglipron tablet once daily |
| Placebo | Active comparator | Drug: PlaceboPlacebo matching Elecoglipron tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Left ventricular ejection fraction (LVEF) of > 40% within 12 months prior to screening.
- Structural heart disease evidence.
- HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
Key exclusion criteria (16 listed)
- BMI <25 kg/m² at screening.
- Diabetes exclusions:
- History of type 1 diabetes.
- HbA1c ≥10% at screening.
- Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
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 |
|---|---|---|
| ElecoglipronElecoglipron tablet | Drug | Elecoglipron |
| PlaceboPlacebo tablet | Drug | Placebo |
Primary outcome
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
Time frame: Up to 42 months
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
3 secondary outcomes
To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)
Time frame: Up to 42 months
To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.
Time frame: Baseline and 52 weeks
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke
Time frame: Up to 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- 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 shared.
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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.
AstraZeneca Clinical Study Information Center contact
679 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elecoglipron in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF), run by AstraZeneca at 679 sites in 32 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 679 sites in United States, China, Japan, Germany, Canada and 27 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit (time frame: Up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026; AzTrials last refreshed its copy on 3 Nov 2026.