Phase
Condition
Diabetes Prevention
Obesity
Treatment
Oral Azelaprag (BGE-105)
Tirzepatide
Tirzepatide Placebo
Clinical Study ID
Ages > 55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, 55 years of age or older at the time of signing the informedconsent.
Have a BMI between 30 and 40 kg/m2 inclusive at the time of screening.
Have a history of at least 1 self-reported unsuccessful dietary effort to lose bodyweight.
Exclusion
Exclusion Criteria:
Have diagnosis of type 1 diabetes (T1D) or Type 2 diabetes (T2D) mellitus.
Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysprior to screening.
Have a prior or planned surgical treatment or device-based therapy for obesity.
Have a family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2).
Have an uncontrolled thyroid disease.
Have obesity induced by endocrinological disorders.
Have biopsy-confirmed nonalcoholic steatohepatitis (NASH), also known as metabolicdysfunction-associated steatohepatitis (MASH).
Have a known history or presence of severe active acute or chronic livers disease oracute or chronic pancreatitis, or exocrine pancreatic insufficiency.
Have a known history or presence of symptomatic gallbladder disease within the past 2 years.
Have a medically significant cardiovascular condition.
Have a history of active or untreated malignancy within the last 5 years.
Have a history of significant active or unstable major depressive disorder or othersevere psychiatric disorder within the last 2 years.
Have any lifetime history of a suicide attempt.
Have a known clinically significant gastric emptying abnormality.
Have had previous or are currently on treatment with a GLP-1R agonist or tirzepatide (a dual agonist of GLP-1 and GIP receptors).
Are currently using warfarin.
Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening.
Have current or history of treatment with medications that may cause significantweight gain within 90 days of screening.
Study Design
Study Description
Connect with a study center
Site 110
Mesa, Arizona 85210
United StatesSite Not Available
Site 107
Los Angeles, California 90057
United StatesSite Not Available
Site 103
Montclair, California 91763
United StatesSite Not Available
Site 105
Spring Valley, California 91978
United StatesSite Not Available
Site 114
Macon, Georgia 31210
United StatesSite Not Available
Site 100
Louisville, Kentucky 40213
United StatesSite Not Available
Site 101
Marrero, Louisiana 70072
United StatesSite Not Available
Site 112
Boston, Massachusetts 02114
United StatesSite Not Available
Site 111
Troy, Michigan 48098
United StatesSite Not Available
Site 113
Saint Peters, Missouri 63303
United StatesSite Not Available
Site 106
Butte, Montana 59701
United StatesSite Not Available
Site 109
Fargo, North Dakota 58104
United StatesSite Not Available
Site 108
Beachwood, Ohio 44122
United StatesSite Not Available
Site 102
Dallas, Texas 75230
United StatesSite Not Available
Site 104
Saint George, Utah 84790
United StatesSite Not Available
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