KAI-9531 for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Kailera

Disqualifiers: Cardiovascular, Pulmonary, Hepatic, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day per treatment period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well the new drug, KAI-9531, is absorbed when injected into different body parts—specifically the abdomen, thigh, and upper arm. The goal is to determine the most effective injection site for individuals dealing with obesity. Suitable candidates for this trial have a body mass index (BMI) between 25 and 40, weigh no more than 120 kg, and are generally healthy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that KAI-9531 is likely to be safe for humans?

Research has shown that KAI-9531 was safe for participants in earlier studies, with most tolerating it well. Participants who took KAI-9531 effectively lost weight and saw improvements in blood pressure, blood sugar, and triglyceride levels. Importantly, these studies reported no major safety issues. Compared to other similar treatments, KAI-9531 demonstrated similar safety results. This suggests that KAI-9531 could be a safe choice for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about KAI-9531 because it offers a new approach to tackling obesity through a unique subcutaneous injection method. Unlike traditional treatments that often include oral medications or lifestyle changes, KAI-9531 is administered directly into the body, with specific sites like the abdomen, thigh, or upper arm, potentially leading to more targeted and efficient results. This delivery method might enhance the drug's effectiveness and reduce side effects, making it a promising option in the fight against obesity.

What evidence suggests that KAI-9531 might be an effective treatment for obesity?

Research has shown that KAI-9531, a new medication, offers promising results for weight loss in treating obesity. In earlier studies, participants lost an average of 19.2% of their body weight after taking a 6 mg dose for 48 weeks. This treatment activates certain receptors in the body that help control appetite and metabolism, leading to significant weight loss. In this trial, participants will receive KAI-9531 as a subcutaneous injection at different sites, including the abdomen, thigh, or upper arm, to evaluate its effectiveness and safety. These findings suggest that KAI-9531 could effectively help people lose weight. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with varying body mass indices, including those who are considered healthy as well as those with childhood or adult obesity. Participants will receive a single dose of KAI-9531 to study how the injection site affects its absorption into the body.

Inclusion Criteria

Body mass index (BMI) must be ≥ 25.0 and ≤ 40.0 kilograms per square meter (kg/m^2), with a body weight ≤ 120 kg

I am in good health.

Exclusion Criteria

I have a significant health condition affecting my heart, lungs, liver, kidneys, blood, stomach, hormones, immune system, skin, mental health, or nervous system.

I haven't had any cancer except for skin cancer that was surgically removed in the last 10 years.

Known hypersensitivity to the study drug or any of the study drug ingredients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of KAI-9531 via subcutaneous injection at different sites (abdomen, thigh, upper arm) across three treatment periods

1 day per treatment period

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after each injection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KAI-9531

Trial Overview The study aims to compare how well KAI-9531 is absorbed when injected at different sites: the upper arm, thigh, and abdomen. It's designed to see if where you get the shot changes how much of the drug gets into your bloodstream.

How Is the Trial Designed?

Group I: KAI-9531: Upper Arm Injection Site Experimental Treatment 1 Intervention

Participants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3.

Group II: KAI-9531: Thigh Injection Site Experimental Treatment 1 Intervention

Participants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3.

Group III: KAI-9531: Abdomen Injection Site Experimental Treatment 1 Intervention

Participants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3.

Who Is Running the Clinical Trial?

Kailera

Lead Sponsor

Citations

1. kailera.com kailera.com/press-release/hengrui-pharma-and-kailera-therapeutics-announce-additional-data-from-phase-3-obesity-trial-in-china-of-dual-glp-1-gip-receptor-agonist-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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07044401

NCT07044401 | A Single-dose Study to Investigate the ... The main objective of the study is to assess the relative bioavailability of KAI-9531 subcutaneous (SC) injection in the upper arm and thigh compared to the ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/hengrui-kailera-obesity-treatment/

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.

4. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/hengrui-kailera-phase-3-obesity-trial-data-revealed-in-china/

Hengrui/Kailera Phase 3 Obesity Trial Data Revealed in ... Hengrui's once-weekly dual GLP-1/GIP agonist HRS9531 delivered 48-week mean weight loss of 11.2%, 17.4%, and 19.2% at 2 mg, 4 mg, and 6 mg, ...

5. withpower.com withpower.com/trial/phase-1-overweight-6-2025-7eb0b

KAI-9531 for Obesity · Info for Participants This trial is for individuals with varying body mass indices, including those who are considered healthy as well as those with childhood or adult obesity.

6. kailera.com kailera.com/wp-content/uploads/2024/09/HRS9531-201_ADA2024_Poster.pdf

Efficacy and Safety of HRS9531, a Novel Dual GLP-1/GIP ... ➢ HRS9531 effectively reduced body weight, blood pressure, blood glucose, and triglycerides, with a favorable safety profile. ➢ These data support further ...

7. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388644

ANZCTR - Registration The purpose of the study is to examine the safety, tolerability and PK of KAI-9531 in a non- Asian and Asian population. Participants will attend the study site ...