KAI-9531 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-9531, an experimental drug, to evaluate its impact on weight loss in individuals with obesity. Participants will receive weekly injections of either varying doses of KAI-9531 or a placebo for comparison. The goal is to determine KAI-9531's effectiveness in reducing body weight. It suits those with a BMI of 35 or higher who have unsuccessfully attempted weight loss through diet and exercise in the past six months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in obesity treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you started medications that may cause significant weight gain within 3 months before the trial, you might not be eligible to participate.
Is there any evidence suggesting that KAI-9531 is likely to be safe for humans?
Research has shown that KAI-9531 has undergone safety testing in people, particularly those with obesity. In these studies, participants generally tolerated KAI-9531 well. This treatment belongs to a group called GLP-1 therapies, which have approval for other uses, indicating a consistent safety record. Although specific side effects for KAI-9531 are not detailed, similar treatments often cause mild to moderate side effects such as nausea or an upset stomach. This trial is in an early phase, focusing on a more thorough safety assessment.12345
Why do researchers think this study treatment might be promising for obesity?
Researchers are excited about KAI-9531 for obesity because it offers a potentially novel approach compared to current treatments like lifestyle modifications, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. KAI-9531 is unique because it may target obesity through a different mechanism, which could lead to more effective weight management. Additionally, the treatment is being tested in various dosages, which allows researchers to find the most effective dose for patients with minimal side effects. This tailored approach could provide a significant advantage over current options, offering hope for those struggling with obesity.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that KAI-9531 can help reduce body weight. In one study, participants taking KAI-9531 lost an average of up to 17.7% of their weight, which is 16.3% more than those who took a placebo (a pill with no active ingredient). Another study found that 59% of participants using KAI-9531 lost 20% or more of their body weight. These findings suggest that KAI-9531 may help people with obesity lose a significant amount of weight.12467
Are You a Good Fit for This Trial?
This trial is for adults with obesity (BMI of 35 or higher) who have tried but failed to lose weight through diet and exercise in the past 6 months. People with diabetes, certain psychiatric conditions, recent use of specific weight-loss drugs, unstable health issues, or a history of some cancers cannot join.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 or placebo by subcutaneous injection once weekly
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 compares weekly injections of KAI-9531 to placebo shots in people living with obesity. The main goal is to see how much body weight changes over time between the two groups.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive Dose 4 of ribupatide once weekly.
Participants will receive Dose 3 of ribupatide once weekly.
Participants will receive Dose 2 of ribupatide once weekly.
Participants will receive Dose 1 of ribupatide once weekly.
Participants will receive placebo matched to ribupatide once weekly.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kailera
Lead Sponsor
Citations
GLP-1 Therapy for Obesity | Ribupatide
Treatment with 8 mg ribupatide injection weekly in a randomized, double-blind, placebo-controlled Phase 2 trial conducted in China resulted in 23.6% weight loss ...
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, Kailera's obesity pill shows 12.1% weight-loss, ...
At the 25-mg dose, 59.1% of participants achieved ≥10% weight loss and 38.6% reached ≥15% weight loss at 26 weeks. Comparable outcomes were seen ...
4.
fiercebiotech.com
fiercebiotech.com/biotech/kailera-hengrui-tout-promising-mid-stage-results-obesity-pillKailera, Hengrui to advance oral obesity drug into 2 new ...
A phase 3 trial of KAI-9531 in China showed in July of last year that it provided a mean weight loss of 19.2% at its highest 6-mg dose after 36 ...
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 ...
6.
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 ...
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 ...
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 semaglutide SC once ...
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