Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over
NCT ID: NCT06515418
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
204 participants
INTERVENTIONAL
2024-06-27
2025-02-12
Brief Summary
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Estimated Study Length:
* with the optional prescreening, the study duration may be up to 48 weeks.
* the treatment duration will be 24 weeks followed by 12 weeks follow-up.
* the visit frequency will be every 2 weeks for the first 8 weeks of the treatment period and every 4 weeks thereafter.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A: Tirzepatide Monotherapy
* Azelaprag placebo every morning
* Azelaprag placebo every evening
* Tirzepatide 5mg once weekly
Oral Placebo for Azelaprag (BGE-105)
Capsules
Tirzepatide
Subcutaneous Injection
B: Azelaprag once daily plus Tirzepatide
* Azelaprag 300mg every morning
* Azelaprag placebo every evening
* Tirzepatide 5mg once weekly
Oral Azelaprag (BGE-105)
Capsules
Oral Placebo for Azelaprag (BGE-105)
Capsules
Tirzepatide
Subcutaneous Injection
C: Azelaprag twice daily plus Tirzepatide
* Azelaprag 300mg every morning
* Azelaprag 300mg every evening
* Tirzepatide 5mg once weekly
Oral Azelaprag (BGE-105)
Capsules
Tirzepatide
Subcutaneous Injection
D: Azelaprag Monotherapy
* Azelaprag 300mg every morning
* Azelaprag 300mg every evening
* Tirzepatide placebo once weekly
Oral Azelaprag (BGE-105)
Capsules
Tirzepatide Placebo
Subcutaneous Injection
Interventions
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Oral Azelaprag (BGE-105)
Capsules
Oral Placebo for Azelaprag (BGE-105)
Capsules
Tirzepatide
Subcutaneous Injection
Tirzepatide Placebo
Subcutaneous Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a BMI between 30 and 40 kg/m2 inclusive at the time of screening.
3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria
2. Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior to screening.
3. Have a prior or planned surgical treatment or device-based therapy for obesity.
4. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
5. Have an uncontrolled thyroid disease.
6. Have obesity induced by endocrinological disorders.
7. Have biopsy-confirmed nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH).
8. Have a known history or presence of severe active acute or chronic livers disease or acute or chronic pancreatitis, or exocrine pancreatic insufficiency.
9. Have a known history or presence of symptomatic gallbladder disease within the past 2 years.
10. Have a medically significant cardiovascular condition.
11. Have a history of active or untreated malignancy within the last 5 years.
12. Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
13. Have any lifetime history of a suicide attempt.
14. Have a known clinically significant gastric emptying abnormality.
15. Have had previous or are currently on treatment with a GLP-1R agonist or tirzepatide (a dual agonist of GLP-1 and GIP receptors).
16. Are currently using warfarin.
17. Have used any weight loss drugs, including herbal or nutritional supplements, within 90 days of screening.
18. Have current or history of treatment with medications that may cause significant weight gain within 90 days of screening.
55 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
BioAge Labs, Inc.
INDUSTRY
Responsible Party
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Locations
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Site 110
Mesa, Arizona, United States
Site 107
Los Angeles, California, United States
Site 103
Montclair, California, United States
Site 105
Spring Valley, California, United States
Site 100
Louisville, Kentucky, United States
Site 101
Marrero, Louisiana, United States
Site 112
Boston, Massachusetts, United States
Site 111
Troy, Michigan, United States
Site 113
City of Saint Peters, Missouri, United States
Site 106
Butte, Montana, United States
Site 109
Fargo, North Dakota, United States
Site 108
Beachwood, Ohio, United States
Site 102
Dallas, Texas, United States
Site 104
St. George, Utah, United States
Countries
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Related Links
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Other Identifiers
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BGE-105-005
Identifier Type: -
Identifier Source: org_study_id
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