KAI-9531 for Obesity

Not currently recruiting at 33 trial locations
KT
Overseen ByKailera Therapeutics, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

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

My BMI is 35 or higher.
History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months

Exclusion Criteria

I have used GLP-1 or similar diabetes medications in the past 3 months.
History of suicide attempt
I have had major depression or another severe mental illness in the past 2 years.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KAI-9531 or placebo by subcutaneous injection once weekly

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Ribupatide: Dose 4Experimental Treatment1 Intervention
Group II: Ribupatide: Dose 3Experimental Treatment1 Intervention
Group III: Ribupatide: Dose 2Experimental Treatment1 Intervention
Group IV: Ribupatide: Dose 1Experimental Treatment1 Intervention
Group V: PlaceboPlacebo Group1 Intervention

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 ...

Kailera, 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 ...

Efficacy 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 ...