KAI-9531 for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called KAI-9531 to determine if it aids in weight loss more effectively than the existing drug semaglutide and a placebo. Participants will receive one of two doses of KAI-9531, semaglutide, or a placebo once a week. The trial seeks individuals with a BMI of 35 or higher who have unsuccessfully attempted weight loss through diet and exercise in the past six months. Participants must not have diabetes or have recently used medications that cause weight gain. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to the development of a new weight loss treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that KAI-9531 has promising safety results. In one study, participants taking KAI-9531 lost significant weight without major safety issues. The treatment was generally well-tolerated, with most participants not experiencing serious side effects.
Semaglutide, the treatment compared to KAI-9531, also has a good safety record. It has shown positive results in other studies. Many participants taking semaglutide experienced benefits, such as a reduced risk of heart problems, and it was generally safe to use.
Both treatments appear well-tolerated in studies, with no major safety concerns reported. This suggests they could be safe options for those considering joining a clinical trial for obesity treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about KAI-9531 for obesity because it offers a potentially novel approach compared to existing treatments like semaglutide. Unlike most obesity medications that primarily target appetite suppression, KAI-9531 may work through a unique mechanism of action, potentially altering how the body processes and stores fat. This could lead to more effective and sustainable weight loss. Additionally, KAI-9531 is administered once weekly, which is convenient and could improve adherence to treatment compared to daily medications.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that KAI-9531, one of the treatments in this trial, holds promise for weight loss in treating obesity. In one study, patients taking 8 mg of KAI-9531 weekly lost 23.6% of their body weight. Another study found an average weight loss of 19.2% with a different dose, and the weight loss did not slow down. This positions KAI-9531 as a strong option compared to other obesity treatments.
Similarly, semaglutide, another treatment option in this trial, has also proven effective for weight loss. People taking semaglutide lost an average of 15.7 kg (about 34.6 pounds) more than those not using any obesity medication. In another study, participants lost an average of 14.9% of their body weight over 68 weeks. Both KAI-9531 and semaglutide have strong evidence supporting their effectiveness in aiding weight loss.24678Are You a Good Fit for This Trial?
This trial is for adults with obesity, having a BMI of at least 35 kg/m^2, who have tried and failed to lose weight through diet and exercise in the last 6 months. It's not for those who've recently taken meds that affect weight, had significant weight changes lately, pancreatitis history, used certain diabetes drugs recently, have gastrointestinal issues or diabetes, a family history of specific cancers, uncontrolled high blood pressure or unstable heart disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KAI-9531, semaglutide, or placebo once weekly to assess changes in body weight
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KAI-9531
- Placebo
- Semaglutide
Trial Overview
The study aims to see if KAI-9531 injections once a week are better than semaglutide (another drug) and placebo at reducing body weight percentage. Participants will receive one of these treatments weekly and their weight loss progress will be compared.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants will receive Dose 2 of KAI-9531 once weekly.
Participants will receive Dose 1 of KAI-9531 once weekly.
Participants will receive semaglutide 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 ...
GLP-1 Therapy for Obesity | KAI-9531
Treatment with 8 mg KAI-9531 injection weekly in a randomized, double-blind, placebo-controlled Phase 2 trial conducted in China resulted in 23.6% weight loss ...
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 ...
Mid-stage study puts Hengrui, Kailera obesity drug in ...
The companies said 59% of HRS9531-treated participants achieved weight loss of 20% or more. The results position HRS9531 competitively against ...
Efficacy and Safety of KAI-9531 Administered Once Weekly ...
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes.
Hengrui, Kailera report Phase III trial data of obesity treatment
Hengrui Pharma and Kailera Therapeutics have reported positive topline data from the former's Phase III trial (HRS9531-301) of HRS9531.
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 previ...
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