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

What Was Tested

The trial (phase 2) is built around Tirzepatide.

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.

It had four arms (groups): A: Tirzepatide Monotherapy (active comparator), B: Azelaprag once daily plus Tirzepatide (experimental), C: Azelaprag twice daily plus Tirzepatide (experimental) and D: Azelaprag Monotherapy (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 204 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 18 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-06-27 with completion listed for 2025-02-06.

It ran at 14 sites in United States (14).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Percent Change in Body Weight (Azelaprag Once per Day) (time frame: Week 24). Mean Percent Change in Body Weight (Azelaprag Twice per Day) (time frame: Week 24).

It also tracked 8 secondary outcomes, for example Body Weight Change, Waist Circumference Change, Serious Adverse Events and Treatment Emergent Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 204 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.