Clinical trial NCT06515418: Efficacy and Safety of Oral Azelaprag Plus Once Weekly Tirzepatide Compared with Tirzepatide Alone in Participants with Obesity Aged 55 Years and Over
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Keywords: Azelaprag
BGE-105
BioAge
Tirzepatide
Weight Management
GLP-1/GIP Receptor Agonist
STRIDES
Lead sponsor: BioAge Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2024-07-23
Enrollment: 204
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Percent Change in Body Weight (Azelaprag Once per Day)
timeFrame: Week 24
measure: Mean Percent Change in Body Weight (Azelaprag Twice per Day)
timeFrame: Week 24
Secondary outcomes:
measure: ≥5% Body Weight Reduction
timeFrame: Week 24
measure: ≥10% Body Weight Reduction
timeFrame: Week 24
measure: ≥15% Body Weight Reduction
timeFrame: Week 24
measure: ≥20% Body Weight Reduction
timeFrame: Week 24
measure: Body Weight Change
timeFrame: Week 24
measure: Waist Circumference Change
timeFrame: Week 24
measure: Serious Adverse Events
timeFrame: Up to Week 36
measure: Treatment Emergent Adverse Events
timeFrame: Up to Week 36
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Site 110
state: Arizona
city: Los Angeles
country: United States
facility: Site 107
state: California
city: Montclair
country: United States
facility: Site 103
state: California
city: Spring Valley
country: United States
facility: Site 105
state: California
city: Louisville
country: United States
facility: Site 100
state: Kentucky
city: Marrero
country: United States
facility: Site 101
state: Louisiana
city: Boston
country: United States
facility: Site 112
state: Massachusetts
city: Troy
country: United States
facility: Site 111
state: Michigan
city: Saint Peters
country: United States
facility: Site 113
state: Missouri
city: Butte
country: United States
facility: Site 106
state: Montana
city: Fargo
country: United States
facility: Site 109
state: North Dakota
city: Beachwood
country: United States
facility: Site 108
state: Ohio
city: Dallas
country: United States
facility: Site 102
state: Texas
city: Saint George
country: United States
facility: Site 104
state: Utah
Study officials:
References: