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

Phase 2

Suspended

• Conditions: Obesity
• Interventions: Drug: Oral Azelaprag (BGE-105); Drug: Oral Placebo for Azelaprag (BGE-105); Drug: Tirzepatide Placebo; Drug: Tirzepatide

• Registration Number: NCT06515418
• Lead Sponsor: BioAge Labs, Inc.

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 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.

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 Timeline

• Study Start: 2024-06-27
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-01-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 204

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C: Azelaprag twice daily plus Tirzepatide	Oral Azelaprag (BGE-105)	* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide 5mg once weekly
B: Azelaprag once daily plus Tirzepatide	Oral Placebo for Azelaprag (BGE-105)	* Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
D: Azelaprag Monotherapy	Tirzepatide Placebo	* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide placebo once weekly
B: Azelaprag once daily plus Tirzepatide	Oral Azelaprag (BGE-105)	* Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
A: Tirzepatide Monotherapy	Oral Placebo for Azelaprag (BGE-105)	* Azelaprag placebo every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
D: Azelaprag Monotherapy	Oral Azelaprag (BGE-105)	* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide placebo once weekly
A: Tirzepatide Monotherapy	Tirzepatide	* Azelaprag placebo every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
B: Azelaprag once daily plus Tirzepatide	Tirzepatide	* Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly
C: Azelaprag twice daily plus Tirzepatide	Tirzepatide	* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide 5mg once weekly

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in Body Weight (Azelaprag Once per Day)	Week 24	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
Mean Percent Change in Body Weight (Azelaprag Twice per Day)	Week 24	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

Secondary Outcome Measures

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

Trial Locations

Locations (14)

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; 🇺🇸 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; 🇺🇸 Saint George, Utah, United States