Apply to Trial

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

204 Participants Needed

Azelaprag + Tirzepatide for Obesity
(STRIDES Trial)

Recruiting at 14 trial locations

Overseen ByCentral Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioAge Labs, Inc.

Must not be taking: GLP-1R agonists, Warfarin

Disqualifiers: Diabetes, Thyroid disease, Liver disease, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop all current medications. However, you cannot participate if you are currently using warfarin, have used weight loss drugs or supplements within 90 days of screening, or have been treated with medications that may cause significant weight gain within 90 days of screening.

What data supports the idea that Azelaprag + Tirzepatide for Obesity is an effective drug?

The available research shows that tirzepatide, part of the Azelaprag + Tirzepatide combination, is effective for weight loss. In studies, people using tirzepatide lost between 16.5% to 22.4% of their body weight over 72 weeks. This is a significant reduction compared to other treatments. Tirzepatide also showed better results than other common medications for diabetes and obesity, like semaglutide and insulin. These findings suggest that tirzepatide is a powerful option for managing obesity.¹ ² ³ ⁴ ⁵

What safety data is available for Azelaprag + Tirzepatide in treating obesity?

The safety data for tirzepatide, a dual GIP and GLP-1 receptor agonist, has been evaluated in several clinical trials, including the SURPASS and SURMOUNT-1 studies. These trials have shown that tirzepatide is well tolerated with a side-effect profile similar to GLP-1 receptor analogues. Adverse effects were comparable to those seen with other GLP-1 receptor agonists, and the treatment was generally well tolerated over periods of up to 104 weeks. While specific safety data for the combination of Azelaprag and Tirzepatide is not detailed in the provided research, the existing data on tirzepatide alone suggests a favorable safety profile in the context of obesity management.¹ ³ ⁵ ⁶ ⁷

Is the drug Azelaprag + Tirzepatide a promising treatment for obesity?

Yes, the drug Azelaprag + Tirzepatide is promising for obesity treatment. Tirzepatide, part of this combination, has shown significant weight loss results in studies, reducing body weight by up to 22.4% in people without diabetes. It works by activating two gut hormones that help control blood sugar and reduce weight, making it a powerful option for managing obesity.¹ ² ⁷ ⁸ ⁹

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 55 and over who are dealing with obesity. Participants must be willing to take oral medication daily or twice a day, receive weekly injections, and commit to the study schedule including follow-ups.

Inclusion Criteria

History of at least 1 self-reported unsuccessful dietary effort to lose body weight

BMI between 30 and 40 kg/m2 inclusive at the time of screening

I am 55 years old or older.

Exclusion Criteria

Lifetime history of a suicide attempt

Known clinically significant gastric emptying abnormality

I have had gallbladder problems in the last 2 years.

See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral azelaprag and/or tirzepatide for weight management

24 weeks

Visits every 2 weeks for the first 8 weeks, then every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

Oral Azelaprag
Tirzepatide

Trial Overview The effectiveness of combining a new oral drug called Azelaprag (taken once or twice daily) with Tirzepatide (a weekly injection) for weight management in older adults is being tested against using Tirzepatide alone.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: D: Azelaprag MonotherapyExperimental Treatment2 Interventions

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

Group II: C: Azelaprag twice daily plus TirzepatideExperimental Treatment2 Interventions

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

Group III: B: Azelaprag once daily plus TirzepatideExperimental Treatment3 Interventions

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

Group IV: A: Tirzepatide MonotherapyActive Control2 Interventions

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

BioAge Labs, Inc.

Lead Sponsor

Trials

Recruited

410+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Tirzepatide, a dual GLP-1/GIP receptor co-agonist, has been shown to significantly reduce glycosylated hemoglobin levels (1.87% to 3.02%) and body weight (5.4 to 12.9 kg) in people with type 2 diabetes over treatment periods of up to 104 weeks, demonstrating its efficacy compared to placebo and other diabetes medications.

In individuals without diabetes, tirzepatide also led to substantial weight loss (16.5% to 22.4%) over 72 weeks, indicating its potential for obesity management as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management.Sinha, R., Papamargaritis, D., Sargeant, JA., et al.[2023]

Tirzepatide significantly reduces body weight in patients with type 2 diabetes and obesity, with an average weight loss of -9.81 kg compared to placebo, based on a meta-analysis of 10 studies involving 9,873 patients.

While tirzepatide is effective for weight loss, it has a higher incidence of gastrointestinal side effects compared to placebo, although serious adverse events and hypoglycemia are less common, indicating a need for monitoring these reactions during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss efficiency and safety of tirzepatide: A Systematic review.Lin, F., Yu, B., Ling, B., et al.[2023]

In a systematic review of randomized controlled trials involving 5800 patients, tirzepatide was found to be highly effective for weight loss, with 78.22% achieving at least 5% weight loss and 32.28% achieving at least 15% weight loss.

Tirzepatide demonstrated superior weight loss compared to placebo and semaglutide, with a significant mean weight loss of -12.47 kg at the 5 mg dose, while showing a manageable safety profile with only a slight increase in gastrointestinal adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis.Tan, B., Pan, XH., Chew, HSJ., et al.[2023]