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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Proof-of-Concept Study to Investigate Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over (STRIDES)

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Oral Placebo for Azelaprag (BGE-105); Drug: Tirzepatide; Drug: Oral Azelaprag (BGE-105); Drug: Tirzepatide Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85210
      • Site 110
  • California
    • Los Angeles, California, United States, 90057
      • Site 107
    • Montclair, California, United States, 91763
      • Site 103
    • Spring Valley, California, United States, 91978
      • Site 105
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Site 100
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Site 101
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Site 112
  • Michigan
    • Troy, Michigan, United States, 48098
      • Site 111
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • Site 113
  • Montana
    • Butte, Montana, United States, 59701
      • Site 106
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Site 109
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Site 108
  • Texas
    • Dallas, Texas, United States, 75230
      • Site 102
  • Utah
    • Saint George, Utah, United States, 84790
      • Site 104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, 55 years of age or older at the time of signing the informed consent.
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:

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A: Tirzepatide Monotherapy; Azelaprag placebo every morning; Azelaprag placebo every evening; Tirzepatide 5mg once weekly	Drug: Oral Placebo for Azelaprag (BGE-105); Capsules; Other Names: Placebo; Drug: Tirzepatide; Subcutaneous Injection
Experimental: B: Azelaprag once daily plus Tirzepatide; Azelaprag 300mg every morning; Azelaprag placebo every evening; Tirzepatide 5mg once weekly	Drug: Oral Placebo for Azelaprag (BGE-105); Capsules; Other Names: Placebo; Drug: Tirzepatide; Subcutaneous Injection; Drug: Oral Azelaprag (BGE-105); Capsules; Other Names: BGE-105
Experimental: C: Azelaprag twice daily plus Tirzepatide; Azelaprag 300mg every morning; Azelaprag 300mg every evening; Tirzepatide 5mg once weekly	Drug: Tirzepatide; Subcutaneous Injection; Drug: Oral Azelaprag (BGE-105); Capsules; Other Names: BGE-105
Experimental: D: Azelaprag Monotherapy; Azelaprag 300mg every morning; Azelaprag 300mg every evening; Tirzepatide placebo once weekly	Drug: Oral Azelaprag (BGE-105); Capsules; Other Names: BGE-105; Drug: Tirzepatide Placebo; Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Body Weight (Azelaprag Once per Day)	Mean percent change in body weight from baseline to Week 24 in the 300 mg azelaprag once per day (QD) plus tirzepatide arm compared to tirzepatide alone arm	Week 24
Mean Percent Change in Body Weight (Azelaprag Twice per Day)	Mean percent change in body weight from baseline to Week 24 in the 300 mg azelaprag twice per day (BID) plus tirzepatide arm compared to tirzepatide alone arm	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
≥5% Body Weight Reduction	Proportion of study participants at 24 weeks who achieve ≥5% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone	Week 24
≥10% Body Weight Reduction	Proportion of study participants at 24 weeks who achieve ≥10% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone	Week 24
≥15% Body Weight Reduction	Proportion of study participants at 24 weeks who achieve ≥15% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone	Week 24
≥20% Body Weight Reduction	Proportion of study participants at 24 weeks who achieve ≥20% body weight reduction from baseline for azelaprag plus tirzepatide compared to tirzepatide alone	Week 24
Body Weight Change	Change from baseline in body weight (kg) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone	Week 24
Waist Circumference Change	Change from baseline in in waist circumference (cm) at 24 weeks for azelaprag plus tirzepatide compared to tirzepatide alone	Week 24
Serious Adverse Events	The incidence of serious adverse events (SAEs)	Up to Week 36
Treatment Emergent Adverse Events	The incidence of treatment emergent adverse events	Up to Week 36

Collaborators and Investigators

• Sponsor: BioAge Labs, Inc.
• Collaborators: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Zepbound™ USPI

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): February 12, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Weight Management; Tirzepatide; BioAge; Azelaprag; BGE-105; GLP-1/GIP Receptor Agonist; STRIDES
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: BGE-105-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No