Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight and 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

2025-523510-87-00

ClinicalTrials.gov

NCT07284901

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Others, Pharmacodynamic

To demonstrate KAI-9531 SC QW is superior to placebo on percent change in body weight and change in hemoglobin A1c (HbA1c)

Secondary objectives 8

1. Controlled for Type I error: To demonstrate that KAI-9531 SC QW is superior to placebo on percent change in body weigh
2. Controlled for Type I error: To demonstrate that KAI-9531 SC QW is superior to placebo on change in HbA1c
3. Controlled for Type I error: To demonstrate that KAI-9531 SC QW is superior to placebo on change in body weight, waist circumference, fasting blood glucose, HbA1c, SBP, lipid parameters, and IWQOL-Lite-CT
4. Controlled for Type I error: To demonstrate that KAI-9531 SC QW is superior to placebo on percent change in body weight in subgroup of participants with BMI ≥35 kg/m2
5. Not controlled for Type I error: To evaluate the effects of KAI9531 SC QW maintenance doses compared to placebo on body weight, BMI, DBP, additional glycemic and lipid parameters, and participant-reported outcomes (COEQ and FNQ)
6. Not controlled for Type I error: To evaluate the safety and tolerability of KAI-9531 SC QW maintenance doses compared to placebo
7. Not controlled for Type I error : To evaluate the immunogenicity of KAI-9531 SC QW maintenance doses compared to placebo
8. 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 4

1. Diagnosis of T2DM
2. Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucosedependent insulinotropic polypeptide receptor (GIPR) dual agonist, or DPP-4 inhibitors
3. BMI ≥27 kg/m2
4. History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.

Exclusion criteria 12

1. Current diagnosis or history of T1DM or any other type of diabetes except T2DM.
2. History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
3. History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
4. 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.
5. Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
6. Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
7. Uncontrolled hypertension or unstable cardiovascular disease
8. History of chronic or acute pancreatitis.
9. Known clinically significant gastric emptying abnormality (eg, severe gastroparesis, gastric outlet obstruction, or inflammatory bowel disease/irritable bowel syndrome) or chronic treatment with medications that directly affect GI motility if taken for >30 days continually within 3 months prior to Screening.
10. History of suicide attempt.
11. History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within 2 years prior to Screening.
12. Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP‑1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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. Change in hemoglobin A1c (%) from baseline at Week 76

Secondary endpoints 8

1. Controlled for Type I error Percent change in body weight (kg) from baseline at Week 76
2. Controlled for Type I error Change in hemoglobin A1c (%) from baseline at Week 76
3. Percentage of participants with ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% reduction in body weight (kg) • Change in waist circumference (cm) • Change in absolute weight (kg) • Percentage of participants with HbA1c <7% and ≤6.5% • Change in fasting blood glucose (mg/dL • Change in SBP (mm Hg) • Percent change in fasting: − Triglycerides (mg/dL) − HDL-cholesterol (mg/dL) − Non-HDL-cholesterol (mg/dL) • Change in IWQOL-Lite-CT physical function composite score
4. Controlled for Type I error: Percent change in body weight (kg) from baseline at Week 76 in subgroup of participants with BMI ≥35 kg/m2
5. Not controlled for Type I error:From baseline at Week 76:Percentage of participants with ≥30% reduction in body weight (kg).Change in BMI (kg/m2).Percentage of participants with HbA1c <5.7%.Change in DBP (mm Hg).Percent change in fasting:Total cholesterol (mg/dL)−LDL-cholesterol (mg/dL)−VLDL-cholesterol (mg/dL)−insulin (mIU/L).Change in Control of Eating Questionnaire (COEQ).Change (all KAI-9531 doses combined) in Food Noise Questionnaire (FNQ) score
6. Not controlled for Type I error: • Treatment-emergent adverse events (TEAEs)
7. Not controlled for Type I error: • Antidrug antibodies (ADAs) • Neutralizing antibodies (NAbs)
8. Not controlled for Type I error: Concentrations of KAI-9531

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 · 64 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 106 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