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

NCT06515418 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: BGE-105-005
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 14

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.

Conditions

Obesity

Keywords

Azelaprag; BGE-105; BioAge; Tirzepatide; Weight Management; GLP-1/GIP Receptor Agonist; STRIDES

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• ≥5% Body Weight Reduction

  Week 24

• ≥10% Body Weight Reduction

  Week 24

• ≥15% Body Weight Reduction

  Week 24

• ≥20% Body Weight Reduction

  Week 24

• Body Weight Change

  Week 24

Study Arms (4)

A: Tirzepatide Monotherapy

ACTIVE COMPARATOR

* Azelaprag placebo every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly

Drug: Oral Placebo for Azelaprag (BGE-105); Drug: Tirzepatide

B: Azelaprag once daily plus Tirzepatide

EXPERIMENTAL

* Azelaprag 300mg every morning * Azelaprag placebo every evening * Tirzepatide 5mg once weekly

Drug: Oral Azelaprag (BGE-105); Drug: Oral Placebo for Azelaprag (BGE-105); Drug: Tirzepatide

C: Azelaprag twice daily plus Tirzepatide

EXPERIMENTAL

* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide 5mg once weekly

Drug: Oral Azelaprag (BGE-105); Drug: Tirzepatide

D: Azelaprag Monotherapy

EXPERIMENTAL

* Azelaprag 300mg every morning * Azelaprag 300mg every evening * Tirzepatide placebo once weekly

Drug: Oral Azelaprag (BGE-105); Drug: Tirzepatide Placebo

Interventions

Oral Azelaprag (BGE-105) DRUG

Capsules

Also known as: BGE-105

B: Azelaprag once daily plus Tirzepatide; C: Azelaprag twice daily plus Tirzepatide; D: Azelaprag Monotherapy

Oral Placebo for Azelaprag (BGE-105) DRUG

Capsules

Also known as: Placebo

A: Tirzepatide Monotherapy; B: Azelaprag once daily plus Tirzepatide

Tirzepatide DRUG

Subcutaneous Injection

A: Tirzepatide Monotherapy; B: Azelaprag once daily plus Tirzepatide; C: Azelaprag twice daily plus Tirzepatide

Tirzepatide Placebo DRUG

Subcutaneous Injection

D: Azelaprag Monotherapy

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• BioAge Labs, Inc.: lead
• Eli Lilly and Company: collaborator

Study Sites (14)

Site 110

Mesa, Arizona, 85210, United States

Location

Site 107

Los Angeles, California, 90057, United States

Location

Site 103

Montclair, California, 91763, United States

Location

Site 105

Spring Valley, California, 91978, United States

Location

Site 100

Louisville, Kentucky, 40213, United States

Location

Site 101

Marrero, Louisiana, 70072, United States

Location

Site 112

Boston, Massachusetts, 02114, United States

Location

Site 111

Troy, Michigan, 48098, United States

Location

Site 113

City of Saint Peters, Missouri, 63303, United States

Location

Site 106

Butte, Montana, 59701, United States

Location

Site 109

Fargo, North Dakota, 58104, United States

Location

Site 108

Beachwood, Ohio, 44122, United States

Location

Site 102

Dallas, Texas, 75230, United States

Location

Site 104

St. George, Utah, 84790, United States

Location

Related Links

• Zepbound™ USPI

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: June 27, 2024
• Primary Completion: February 6, 2025
• Study Completion: February 12, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)