Azelaprag + Tirzepatide for Obesity
(STRIDES Trial)
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: BioAge Labs, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.
12345What 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.
13567Is 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.
12789Eligibility 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.
+15 more
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Site 113Saint Peters, MO
Site 110Mesa, AZ
Site 107Los Angeles, CA
Site 103Montclair, CA
More Trial Locations
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Who Is Running the Clinical Trial?
BioAge Labs, Inc.Lead Sponsor
Eli Lilly and CompanyIndustry Sponsor
References
Efficacy and Safety of Tirzepatide in Type 2 Diabetes and Obesity Management. [2023]The combination of glucagon-like peptide-1 (GLP-1) with other gut hormones including the glucose-dependent insulinotropic polypeptide (GIP) has been explored to complement and enhance further the GLP-1 effects on glycemia and weight loss. Tirzepatide is the first dual GLP-1/GIP receptor co-agonist which has been approved for treatment of type 2 diabetes mellitus (T2DM) based on the findings from the SURPASS program. The SURPASS trials assessed the safety and efficacy of tirzepatide in people with T2DM, from monotherapy through to insulin add-on in global populations, with another two trials dedicated to Japanese population. Over periods of treatment up to 104 weeks, once weekly tirzepatide 5 to 15 mg reduced glycosylated hemoglobin (1.87% to 3.02%), body weight (5.4 to 12.9 kg) and improved multiple cardiometabolic risk factors (including reduction in liver fat, new-onset macroalbuminuria, blood pressure, and lipids) across the T2DM spectrum. Tirzepatide provided better efficacy than placebo and other commonly used glucose-lowering medications such as semaglutide 1 mg, dulaglutide, insulin degludec, and glargine. All tirzepatide doses were well tolerated with similar side-effect profile to the GLP-1 receptor analogues. In people without diabetes, tirzepatide 5 to 15 mg once weekly for the treatment for obesity (SURMOUNT-1) resulted in substantial reductions in body weight (16.5% to 22.4%) over 72 weeks. Overall, the SURPASS program and SURMOUNT-1 study suggest that tirzepatide is marking a new era in T2DM and/or obesity management through dual agonism of gut hormones.
Weight loss efficiency and safety of tirzepatide: A Systematic review. [2023]Tirzeptide is a novel glucagon-like peptide-1 receptor (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) drug, which shows good efficiency for weight loss. Therefore, we aim to investigate the efficacy and safety of tirzepatide for weight loss in type 2 diabetes mellitus (T2DM) and obesity patients in this meta-analysis study.
Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. [2023]Recent studies suggest that tirzepatide, a dual glucose-dependent insulinotropic-peptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA), has significant weight loss effects. This systematic review and meta-analysis aims to assess the efficacy and safety of tirzepatide for weight loss in patients with overweight or obesity.
SURMOUNTing body weight barriers in type 2 diabetes. [2023]The emergence of GIPR:GLP-1R co-agonists has heralded a renaissance of anti-obesity medication. In the recent SURMOUNT 2 trial, Garvey and colleagues set out to examine the weight loss efficacy of the GIPR:GLP-1R co-agonist tirzepatide in patients with obesity and type 2 diabetes, reporting that tirzepatide has unprecedented efficacy in a magnitude historically considered almost unattainable.1.
New Drug: Tirzepatide (Mounjaro™). [2023]Type 2 diabetes mellitus (T2DM) is the most common form of diabetes and is a chronic and progressive illness. Millions of Americans have T2DM and many patients do not achieve the recommended blood glucose levels. Glucagon-like peptide 1 (GLP-1) based therapy is an established treatment for the management of T2DM and is recommended early in the treatment algorithm. GLP-1 therapy is associated with better glycemic control, weight reduction, and favorable cardiovascular outcomes. Tirzepatide (Mounjaro™) is a novel dual glucose-dependent insulinotropic polypeptide (GIP) receptor and GLP-1 receptor agonist. Evidence from five SURPASS clinical trials has demonstrated that tirzepatide has potent glucose lowering and weight loss with adverse effects comparable to GLP-1 receptor agonists. This paper gives an overview of tirzepatide and SURPASS clinical trials.
Tirzepatide: First Approval. [2022]Tirzepatide (Mounjaro™) is a single molecule that combines dual agonism of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors. Native GIP and GLP-1 are incretin hormones that stimulate insulin secretion and decrease glucagon secretion. GIP also plays a role in nutrient and energy metabolism, while GLP-1 also delays gastric emptying, supresses appetite and improves satiety. Eli Lilly is developing tirzepatide for the treatment of type 2 diabetes mellitus (T2DM), obesity, cardiovascular disorders in T2DM, heart failure, non-alcoholic steatohepatitis, obstructive sleep apnoea and for reducing mortality/morbidity in obesity. In May 2022, tirzepatide received its first approval in the USA to improve glycaemic control in adults with T2DM, as an adjunct to diet and exercise. Tirzepatide is in phase III development for heart failure, obesity and cardiovascular disorders in T2DM, and in phase II development for non-alcoholic steatohepatitis. This article summarizes the milestones in the development of tirzepatide leading to this first approval for T2DM.
Tirzepatide: Clinical review of the "twincretin" injectable. [2023]To provide an overview of the safety and efficacy, pharmacology, dosing, place in therapy, and clinical trials for tirzepatide, a novel glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist for treatment of type 2 diabetes.
Effect of dual glucose-dependent insulinotropic peptide/glucagon-like peptide-1 receptor agonist on weight loss in subjects with obesity. [2023]The occurrence of obesity is an increasing issue worldwide, especially in industrialized countries. Weight loss is important both to treat obesity and to prevent the development of complications. Currently, several drugs are used to treat obesity, but their efficacy is modest. Thus, new anti-obesity treatments are needed. Recently, there has been increased interest in the development of incretins that combine body-weight-lowering and glucose-lowering effects. Therefore, a new drug that simultaneously coactivates both the glucose-dependent insulinotropic polypeptide (GIP) receptor (GIPR) and the glucagon-like peptide-1 receptor (GLP-1R) has been developed. Tirzepatide, the first in this class, improves glycemic control by increasing insulin sensitivity and lipid metabolism as well as by reducing body weight. Combining the activation of the two receptors, greater improvement of β-cell function offers more effective treatment of diabetes and obesity with fewer adverse effects than selective GLP-1R agonists. In the present review, we discuss the progress in the use of GIPR and GLP-1R coagonists and review literature from in vitro studies, animal studies, and human trials, highlighting the synergistic mechanisms of tirzepatide.
Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]Tirzepatide is a novel dual glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1 RA) currently under review for marketing approval. Individual trials have assessed the clinical profile of tirzepatide vs different comparators. We conducted a systematic review and meta-analysis to assess the efficacy and safety of tirzepatide for type 2 diabetes.