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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523486-17-00 | EU Trial (CTIS) Number |
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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 weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAI-9531: Dose 1 | Experimental | Participants will receive Dose 1 of KAI-9531 once weekly. |
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| KAI-9531: Dose 2 | Experimental | Participants will receive Dose 2 of KAI-9531 once weekly. |
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| KAI-9531: Dose 3 | Experimental | Participants will receive Dose 3 of KAI-9531 once weekly. |
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| KAI-9531: Dose 4 | Experimental | Participants will receive Dose 4 of KAI-9531 once weekly. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to KAI-9531 once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAI-9531 | Drug | SC Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 | Baseline, Week 76 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 | Baseline, Week 76 | |
| Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight | Baseline, Week 76 |
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Inclusion Criteria:
BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following:
History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kailera Therapeutics, Inc. | Contact | 781-317-0291 | info-clinicalstudies@kailera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kailera Clinical Site | Recruiting | Anniston | Alabama | 36207 | United States | |
| Kailera Clinical Site |
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| Placebo | Drug | SC Injection |
|
| Change From Baseline in Waist Circumference | Baseline, Week 76 |
| Change From Baseline in Absolute Body Weight | Baseline, Week 76 |
| Change From Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Triglycerides | Baseline, Week 76 |
| Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Non-HDL-cholesterol | Baseline, Week 76 |
| Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score | Baseline, Week 76 |
| Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight | Baseline, Week 76 |
| Percentage of Participants with ≥30% Reduction in Body Weight | Baseline, Week 76 |
| Change From Baseline in BMI | Baseline, Week 76 |
| Change From Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 76 |
| Percent Change From Baseline in Total Cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol | Baseline, Week 76 |
| Percent Change From Baseline in Fasting Insulin | Baseline, Week 76 |
| Change From Baseline in Fasting Blood Glucose | Baseline, Week 76 |
| Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Positive Mood Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Craving for Sweets Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Craving for Savory Food Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Hunger Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Satiety Score | Baseline, Week 76 |
| Change From Baseline in CoEQ Combined Score | Baseline, Week 76 |
| Change From Baseline in Food Noise Questionnaire (FNQ) Score | Baseline, Week 76 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Week 80 |
| Number of Participants With Anti-drug Antibodies (ADAs) | Up to Week 80 |
| Number of Participants With Neutralizing Antibodies (Nabs) | Up to Week 80 |
| Plasma Concentrations of KAI-9531 | Up to Week 76 |
| Recruiting |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Kailera Clinical Site | Recruiting | Cullman | Alabama | 35055 | United States |
| Kailera Clinical Site | Recruiting | Sun City | Arizona | 85351 | United States |
| Kailera Clinical Site | Recruiting | Escondido | California | 92025 | United States |
| Kailera Clinical Site | Recruiting | Toluca Lake | California | 91602 | United States |
| Kailera Clinical Site | Recruiting | Aurora | Colorado | 80012 | United States |
| Kailera Clinical Site | Recruiting | Bridgeport | Connecticut | 06606 | United States |
| Kailera Clinical Site | Recruiting | Jupiter | Florida | 33458 | United States |
| Kailera Clinical Site | Recruiting | Lilburn | Georgia | 30047 | United States |
| Kailera Clinical Site | Recruiting | Springfield | Illinois | 62072 | United States |
| Kailera Clinical Site | Recruiting | Columbia | Maryland | 21045 | United States |
| Kailera Clinical Site | Recruiting | Las Vegas | Nevada | 89119 | United States |
| Kailera Clinical Site | Recruiting | Rochester | New York | 14609 | United States |
| Kailera Clinical Site | Recruiting | Morehead City | North Carolina | 28557 | United States |
| Kailera Clinical Site | Recruiting | Chickasha | Oklahoma | 73018 | United States |
| Kailera Clinical Site | Recruiting | Mauldin | South Carolina | 29662 | United States |
| Kailera Clinical Site | Recruiting | Chattanooga | Tennessee | 37405 | United States |
| Kailera Clinical Site | Recruiting | Amarillo | Texas | 79124 | United States |
| Kailera Clinical Site | Recruiting | Bellaire | Texas | 77401 | United States |
| Kailera Clinical Site | Recruiting | DeSoto | Texas | 75115 | United States |
| Kailera Clinical Site | Recruiting | Tomball | Texas | 77375 | United States |
| Kailera Clinical Site | Recruiting | Salt Lake City | Utah | 84124 | United States |
| Kailera Clinical Site | Recruiting | Danville | Virginia | 24541 | United States |
| Kailera Clinical Site | Recruiting | San Nicolás de los Arroyos | Buenos Aires | 2900 | Argentina |
| Kailera Clinical Site | Recruiting | Buenos Aires | Buenos Aires F.D. | 1060 | Argentina |
| Kailera Clinical Site | Recruiting | CABA | 1061 | Argentina |
| Kailera Clinical Site | Recruiting | Córdoba | 5000 | Argentina |
| Kailera Clinical Site | Recruiting | Silverdale | Auckland | 0932 | Australia |
| Kailera Clinical Site | Recruiting | Charlestown | New South Wales | 2290 | Australia |
| Kailera Clinical Site | Recruiting | Sydney | New South Wales | 2019 | Australia |
| Kailera Clinical Site | Recruiting | Sydney | New South Wales | 2100 | Australia |
| Kailera Clinical Site | Recruiting | Sydney | New South Wales | 2228 | Australia |
| Kailera Clinical Site | Recruiting | Wollongong | New South Wales | 2500 | Australia |
| Kailera Clinical Site | Recruiting | Sippy Downs | Queensland | 4556 | Australia |
| Kailera Clinical Site | Recruiting | Norwood | South Australia | 5067 | Australia |
| Kailera Clinical Site | Recruiting | Heidelberg Heights | Victoria | 3081 | Australia |
| Kailera Clinical Site | Recruiting | Melbourne | Victoria | 3025 | Australia |
| Kailera Clinical Site | Recruiting | Grafton | Auckland | 1010 | New Zealand |
| Kailera Clinical Site | Recruiting | Hamilton | Waikato Region | 3200 | New Zealand |
| Kailera Clinical Site | Recruiting | Auckland | 0610 | New Zealand |
| Kailera Clinical Site | Recruiting | Nelson | 7011 | New Zealand |
| Kailera Clinical Site | Recruiting | Hounslow | YW47NJ | United Kingdom |
| Kailera Clinical Site | Recruiting | London | EC1M 6BQ | United Kingdom |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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