Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Kailera Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2026-05-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Kailera Therapeutics Inc.

External identifiers

EU CT number

2025-523486-17-00

ClinicalTrials.gov

NCT07284875

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Efficacy, Others, Pharmacokinetic

To determine the effects of KAI-9531 SC QW compared to placebo on percent change in body weight

Secondary objectives 7

1. Controlled for Type I error: To determine the effects of KAI-9531 SC QW compared to placebo on percent change in body weight
2. Controlled for Type I error: To evaluate the effects of KAI-9531 SC QW maintenance doses compared to placebo on body weight, waist circumference, SBP, lipid parameters, and patient reported outcomes
3. Controlled for Type I error: To evaluate the effects of KAI-9531 SC QW maintenance doses compared to placebo on body weight in subgroup of participants with BMI ≥35 kg/m2
4. Not controlled for Type I error: To evaluate the effects of KAI9531 SC QW maintenance doses compared to placebo on body weight, DBP, BMI, additional lipid parameters, glycemic parameters, and participant-reported outcome
5. Not controlled for Type I error: To evaluate the safety and tolerability of KAI-9531 SC QW maintenance doses compared to placebo
6. Not controlled for Type I error: To evaluate the immunogenicity of KAI-9531 SC QW maintenance doses
7. Not controlled for Type I error :To characterize the population PK of KAI-9531 SC QW maintenance doses and explore the relationships between the KAI-9531 concentration and efficacy, safety, and tolerability measures

Conditions and MedDRA coding

Obesity

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. BMI ≥30 kg/m², or BMI ≥27 kg/m² with a prior diagnosis of at least one of the following: Hypertension Dyslipidemia Obstructive sleep apnea Cardiovascular disease
2. History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

Exclusion criteria 10

1. Current diagnosis or history of diabetes mellitus
2. Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
3. Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
4. Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
5. Uncontrolled hypertension or unstable cardiovascular disease
6. History of chronic or acute pancreatitis
7. Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect GI motility.
8. History of suicide attempt.
9. History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder
10. Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/GIP, or glucagon receptor agonist within 3 months prior to Screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change in body weight (kg) from baseline at Week 76

Secondary endpoints 7

1. Percent change in body weight (kg) from baseline at Week 76
2. From baseline at Week 76 Percentage of participants with ≥5%,≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) Change in waist circumference (cm) Change in absolute body weight (kg) Change (all KAI-9531 doses combined) in SBP (mm Hg) Percent change (all KAI-9531 doses combined) in (fasting): − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) Change (all KAI-9531 doses combined) in IWQOL-Lite-CT physical function composite score
3. Percent change in body weight (kg) from baseline at Week 76 in the subgroup of participants with BMI ≥35 kg/m2
4. From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight(kg).Change in BMI(kg/m2).Change(all KAI-9531 doses combined) in DBP (mm Hg).Percent change(all KAI-9531 doses combined) in(fasting):−Total cholesterol(mg/dL)−LDL-cholesterol(mg/dL)−VLDL-cholesterol(mg/dL). Percent change(all KAI-9531 doses combined) in fasting insulin (mIU/L).Change(all KAI-9531 doses combined) in fasting blood glucose (mg/dL).Change(all KAI-9531 doses combined) in COEQ
5. TEAEs, clinical laboratory parameters, ECGs, and vital sign
6. ADA NAb
7. Population PK Efficacy, safety, and tolerability exposure-response analysis

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kailera Therapeutics Inc.

Sponsor organisation

Kailera Therapeutics Inc.

Address

890 Winter Street

City

Waltham

Postcode

02451-1470

Country

United States

Scientific contact point

Organisation

Kailera Therapeutics Inc.

Contact name

Kailera Therapeutics, Inc

Public contact point

Organisation

Kailera Therapeutics Inc.

Contact name

Kailera Therapeutics, Inc

Third parties 12

Locations

6 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 110 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications