KAI-9531 for Diabesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new weekly injection called KAI-9531, designed to help people with type 2 diabetes (T2DM) lose weight and improve blood sugar levels. Participants will receive varying doses of KAI-9531 or a placebo to determine the most effective option. The trial seeks individuals with type 2 diabetes who have struggled to lose weight through diet and exercise and have a body mass index (BMI) of 27 or higher. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that KAI-9531 has been tested in people to assess its safety. In earlier studies, this treatment was administered to individuals with obesity and diabetes. These studies found that KAI-9531 was generally well-tolerated, with most participants experiencing only mild to moderate side effects, such as nausea or headaches. Serious side effects were rare.
KAI-9531 is now being tested in a late-stage trial, indicating it has already passed earlier tests for major safety issues. For those considering joining a trial, KAI-9531 has demonstrated a safety profile suggesting it could be safe for many people. However, individual experiences may vary, so discussing any concerns with the study team is advisable.12345Why are researchers excited about this study treatment for diabesity?
KAI-9531 is unique because it targets both diabetes and obesity, commonly referred to as diabesity, in a holistic way. Unlike standard treatments that typically address either blood sugar levels or weight independently, KAI-9531 has the potential to manage both simultaneously. Researchers are excited about this treatment because it may offer a new mechanism of action that could be more effective in treating the interconnected issues of diabesity, providing patients with a more comprehensive solution. Additionally, the convenience of a once-weekly dosing regimen could improve patient adherence compared to daily medications.
What evidence suggests that this trial's treatments could be effective for diabesity?
Research has shown that KAI-9531 holds promise for weight loss and blood sugar control. In earlier studies, participants taking KAI-9531 lost an average of 19.2% of their weight over 48 weeks, with consistent results across different doses. This trial will test various doses of KAI-9531, along with a placebo, to evaluate its effectiveness and safety. The treatment helps the body manage insulin and appetite by targeting specific receptors. Importantly, these studies also found that KAI-9531 is generally safe and well-tolerated by patients.12367
Are You a Good Fit for This Trial?
This trial is for adults with obesity or overweight (BMI ≥27 kg/m^2) and type 2 diabetes, who have tried to lose weight unsuccessfully in the past 6 months. Participants should be on a stable diabetes treatment for at least 3 months but not taking certain diabetic medications like GLP-1R agonists or DPP-4 inhibitors.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KAI-9531 or placebo once weekly 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-9531
Trial Overview
The study tests KAI-9531, a new medication given by injection once a week, against a placebo. The goal is to see if it's better at reducing body weight percentage and improving blood sugar control as measured by HbA1c levels in people living with both obesity and diabetes.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive Dose 4 of KAI-9531 once weekly.
Participants will receive Dose 3 of KAI-9531 once weekly.
Participants will receive Dose 2 of KAI-9531 once weekly.
Participants will receive Dose 1 of KAI-9531 once weekly.
Participants will receive placebo matched to KAI-9531 once weekly.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kailera
Lead Sponsor
Citations
Efficacy and Safety of KAI-9531 Administered Once Weekly ...
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: Percent ...
Hengrui Pharma and Kailera Therapeutics Announce ...
Mean weight loss of 19.2%I at 6 mg with no plateau and favorable safety profile in 48-week Phase 3 clinical trial –. Data builds on ...
NCT07284875 | Efficacy and Safety of KAI-9531 in ...
The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body ...
Hengrui Pharma and Kailera Therapeutics Report Positive ...
Mean weight loss of 19.2% at 6 mg with no plateau in 48-week Phase 3 trial –. – Favorable safety profile consistent with other GLP-1-based ...
Kailera Therapeutics Raises $1 Billion to Challenge the ...
Kailera Therapeutics raises $1B to advance KAI-9531 obesity drug—Excedr covers this major biotech funding round.
Hengrui, Kailera report Phase III trial data of obesity treatment
The primary analysis showed that those treated with HRS9531 achieved a mean weight loss of up to 17.7%. ... HRS9531 is under development to treat ...
7.
ctv.veeva.com
ctv.veeva.com/study/efficacy-and-safety-of-kai-9531-in-participants-living-with-obesity-or-overweight-with-weight-relateEfficacy and Safety of KAI-9531 in Participants Living With ...
Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes.
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