KAI-7535 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called KAI-7535, a potential weight loss drug, to determine its effectiveness in helping people lose weight. It targets individuals who are obese or overweight and have at least one related health issue, such as high blood pressure or sleep apnea, but do not have diabetes. The trial will also evaluate KAI-7535's effectiveness in those with type 2 diabetes. Participants will receive either KAI-7535 or a placebo to compare effects. Ideal candidates for the trial are those who struggle with weight, have related health issues, and have not been diagnosed with diabetes. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important weight loss research.
Is there any evidence suggesting that KAI-7535 is likely to be safe for humans?
Research has shown that KAI-7535, a new drug, has undergone safety testing in people. Its safety profile is similar to other drugs that control blood sugar and appetite, known as GLP-1 receptor agonists.
In earlier studies, both single and repeated doses of KAI-7535 were generally well-tolerated. Nausea and vomiting were the most common side effects, typical for this type of medication, and these side effects were consistent across different doses.
Overall, evidence suggests that KAI-7535 is generally safe for people. However, as with any new treatment, monitoring for unexpected reactions remains important.12345Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about KAI-7535 for obesity because it offers a fresh approach compared to existing treatments like lifestyle changes, medications such as orlistat, and surgery. Unlike most current treatments that primarily focus on appetite suppression or fat absorption, KAI-7535 introduces a novel mechanism by potentially targeting specific pathways involved in metabolism. This innovative approach could lead to more effective weight management with possibly fewer side effects. Additionally, the treatment is administered once daily, which may improve patient adherence and convenience.
What evidence suggests that KAI-7535 could be an effective treatment for obesity?
Research has shown that KAI-7535 yields promising results for weight loss. In one study, 59.1% of participants lost at least 10% of their body weight, and 38.6% lost at least 15%. Another study found that participants lost an average of 4.38 kg (about 6.63% of their body weight) in 29 days. KAI-7535 targets GLP-1 receptors, which help control appetite and insulin levels. These findings suggest that KAI-7535 could effectively aid weight loss in people with obesity. Participants in this trial will receive KAI-7535 under different dose schedules to evaluate its effectiveness and safety.12567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral KAI-7535 or placebo once daily to evaluate efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KAI-7535
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive KAI-7535 once daily.
Participants will receive KAI-7535 once daily.
Participants will receive KAI-7535 once daily.
Participants will receive KAI-7535 once daily.
Participants will receive placebo matched to KAI-7535 once daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kailera
Lead Sponsor
Citations
1.
kailera.com
kailera.com/wp-content/uploads/2025/06/Phase_2_clinical_trial_of_HRS-7535_in_adults_with_type_2_diabetes_ADA2025.pdfEfficacy and Safety of a Novel Oral Small Molecule ...
➢. HRS-7535 is a novel oral small-molecule GLP-1RA currently being developed for T2DM, obesity, and diabetic kidney disease. ➢. This phase 2, 16-week, double- ...
NCT07294898 | A Study to Investigate the Effect of a Low- ...
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants ...
Kailera Therapeutics and Hengrui Pharma Report Positive ...
Additionally, at the 25 mg dose, 59.1% of participants achieved at least 10% weight loss, and 38.6% of participants achieved at least 15% weight ...
S-1/A
In addition, results showed that the PK of KAI-7535 correlated with the participant's weight for both Asian and non-Asian participants ...
KAI-7535 for Obesity · Info for Participants
What evidence suggests that this trial's treatments could be effective for obesity? Research has shown that KAI-7535 yields promising results in weight loss.
A phase 1, randomized, double-blind, placebo-controlled, ...
HRS-7535 exhibited a safety and tolerability profile consistent with other GLP-1RAs and showed PKs suitable for once-daily dosing.
PowerPoint 演示文稿
Conclusions: ➢ Both SAD and MAD of HRS-7535 showed acceptable safety profile and favorable PKs/PDs. ➢ The obvious reductions in body weight ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.