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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living with Obesity or Overweight with Weight-Related Comorbidities Who Do Not Have Diabetes

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523486-17-00
Enrollment
79
Registered
2026-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

Detailed description

Percent change in body weight (kg) from baseline at Week 76, 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, Percent change in body weight (kg) from baseline at Week 76 in the subgroup of participants with BMI ≥35 kg/m2, 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, TEAEs, clinical laboratory parameters, ECGs, and vital sign, ADA NAb, Population PK Efficacy, safety, and tolerability exposure-response analysis

Interventions

Sponsors

Kailera Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change in body weight (kg) from baseline at Week 76

Secondary

MeasureTime frame
Percent change in body weight (kg) from baseline at Week 76, 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, Percent change in body weight (kg) from baseline at Week 76 in the subgroup of participants with BMI ≥35 kg/m2, 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 (

Outcome results

None listed

Source: EU CTIS · Data processed: May 6, 2026