Status:
TERMINATED
Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over
Lead Sponsor:
BioAge Labs, Inc.
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Obesity
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
This study aims to find out how well a combination of oral azelaprag taken once a day (QD) or twice a day (BID), along with a weekly injection of tirzepatide, works for weight management in adults 55 ...
Detailed Description
Clinical trial BGE-105-005 will determine if the addition of oral azelaprag to tirzepatide treatment will amplify overall weight loss in participants with obesity aged 55 years and older. BGE-105-005 ...
Eligibility Criteria
Inclusion
- Male or female, 55 years of age or older at the time of signing the informed consent.
- 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 body weight.
Exclusion
- 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 days prior 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 multiple endocrine 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 metabolic dysfunction-associated steatohepatitis (MASH).
- Have a known history or presence of severe active acute or chronic livers disease or acute 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 other severe 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 significant weight gain within 90 days of screening.
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2025
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06515418
Start Date
June 27 2024
End Date
February 12 2025
Last Update
March 13 2025
Active Locations (14)
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1
Site 110
Mesa, Arizona, United States, 85210
2
Site 107
Los Angeles, California, United States, 90057
3
Site 103
Montclair, California, United States, 91763
4
Site 105
Spring Valley, California, United States, 91978