Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over

Last updated: March 11, 2025
Sponsor: BioAge Labs, Inc.
Overall Status: Terminated

Phase

2

Condition

Diabetes Prevention

Obesity

Treatment

Oral Azelaprag (BGE-105)

Tirzepatide

Tirzepatide Placebo

Clinical Study ID

NCT06515418
BGE-105-005
  • Ages > 55
  • All Genders

Study 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 years and older. The researchers are also looking at safety.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, 55 years of age or older at the time of signing the informedconsent.

  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 bodyweight.

Exclusion

Exclusion Criteria:

  1. Have diagnosis of type 1 diabetes (T1D) or Type 2 diabetes (T2D) mellitus.

  2. Have a self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysprior 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 multipleendocrine 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 metabolicdysfunction-associated steatohepatitis (MASH).

  8. Have a known history or presence of severe active acute or chronic livers disease oracute 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 othersevere 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 significantweight gain within 90 days of screening.

Study Design

Total Participants: 204
Treatment Group(s): 4
Primary Treatment: Oral Azelaprag (BGE-105)
Phase: 2
Study Start date:
June 27, 2024
Estimated Completion Date:
February 12, 2025

Study 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 is a randomized, double-blind, placebo-controlled, parallel-arm, multi-center study in approximately 220 adults ≥55 years old with body mass index (BMI) between 30 and 40 kg/m2 inclusive, at the time of screening. Participants will be randomly assigned to 1 of the 4 study arms (A-tirzepatide monotherapy, B-azelaprag 300 mg QD plus tirzepatide, C-azelaprag 300 mg BID plus tirzepatide, D-azelaprag 300 mg BID monotherapy). The primary endpoint will be the effect on body weight reduction as measured by mean percent change in body weight at 24 weeks in participants that received azelaprag plus tirzepatide versus tirzepatide alone. The study is intended to gather safety and efficacy data in the defined participant population.

Connect with a study center

  • Site 110

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Site 107

    Los Angeles, California 90057
    United States

    Site Not Available

  • Site 103

    Montclair, California 91763
    United States

    Site Not Available

  • Site 105

    Spring Valley, California 91978
    United States

    Site Not Available

  • Site 114

    Macon, Georgia 31210
    United States

    Site Not Available

  • Site 100

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Site 101

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Site 112

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Site 111

    Troy, Michigan 48098
    United States

    Site Not Available

  • Site 113

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Site 106

    Butte, Montana 59701
    United States

    Site Not Available

  • Site 109

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Site 108

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Site 102

    Dallas, Texas 75230
    United States

    Site Not Available

  • Site 104

    Saint George, Utah 84790
    United States

    Site Not Available

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