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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514000-13-00 | Registry Identifier | EU CT number |
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A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index [BMI] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity
The study will comprise of:
A screening period of maximum 28 days
A treatment period of 36 weeks
A follow up period after last dose of study drug
This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Dose 1 |
|
| Arm 2 | Experimental | Dose 2 |
|
| Arm 3 | Experimental | Dose 3 |
|
| Arm 4 | Placebo Comparator | Placebo - Dose matched with each Experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6234 | Drug | IMP injected subcutaneously, once a week. Unit dose strength as per CSP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in body weight from baseline to week 26 | To determine whether AZD6234 is superior to placebo for weight loss | 26 weeks |
| Weight loss ≥ 5% from baseline weight to week 26 | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss ≥ 5% from baseline to week 36 | To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline | 36 weeks |
| Weight loss ≥ 10% from baseline to week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Mobile | Alabama | 36608 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| Placebo comparator | Drug | Placebo matching IMP dose injected subcutaneously, once a week. |
|
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline
| 36 weeks |
| Percent change in body weight from baseline to week 36 | To determine whether AZD6234 is superior to placebo for weight loss | 36 weeks |
| Absolute change in body weight (kg) from baseline to week 26 and week 36 | To determine whether AZD6234 is superior to placebo for absolute weight loss | week 26 and week 36 |
| AZD6234 plasma concentrations | To characterise the PK of AZD6234 | Week 43 |
| Phoenix |
| Arizona |
| 85044 |
| United States |
| Research Site | Long Beach | California | 90815 | United States |
| Research Site | Hialeah | Florida | 33012 | United States |
| Research Site | Largo | Florida | 33777 | United States |
| Research Site | Orlando | Florida | 32825 | United States |
| Research Site | Tampa | Florida | 33606 | United States |
| Research Site | Woodstock | Georgia | 30189 | United States |
| Research Site | Indianapolis | Indiana | 46260 | United States |
| Research Site | Lutherville-Timonium | Maryland | 21093 | United States |
| Research Site | Gulfport | Mississippi | 39503 | United States |
| Research Site | Ridgeland | Mississippi | 39157 | United States |
| Research Site | Kansas City | Missouri | 64111 | United States |
| Research Site | Omaha | Nebraska | 68134 | United States |
| Research Site | Portsmouth | New Hampshire | 03801 | United States |
| Research Site | Statesville | North Carolina | 28625 | United States |
| Research Site | North Charleston | South Carolina | 29405 | United States |
| Research Site | Knoxville | Tennessee | 37938 | United States |
| Research Site | Austin | Texas | 78731 | United States |
| Research Site | Dallas | Texas | 75230 | United States |
| Research Site | Port Arthur | Texas | 77642 | United States |
| Research Site | San Antonio | Texas | 78231 | United States |
| Research Site | San Antonio | Texas | 78249 | United States |
| Research Site | Heidelberg | 3081 | Australia |
| Research Site | Maroochydore | 4556 | Australia |
| Research Site | Maroubra | 2035 | Australia |
| Research Site | Merewether | 2291 | Australia |
| Research Site | Hamilton | Ontario | L8L 5G8 | Canada |
| Research Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Research Site | Stouffville | Ontario | L4A1H2 | Canada |
| Research Site | Toronto | Ontario | M3J 2C5 | Canada |
| Research Site | Montreal | Quebec | H4N 2W2 | Canada |
| Research Site | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Research Site | Chūōku | 103-0027 | Japan |
| Research Site | Chūōku | 104-0031 | Japan |
| Research Site | Shinjuku-ku | 160-0008 | Japan |
| Research Site | Suita-shi | 565-0853 | Japan |
| Research Site | Hull | HU3 2PA | United Kingdom |
| Research Site | Leicester | Le5 4PW | United Kingdom |
| Research Site | Penarth | CF64 2XX | United Kingdom |
| Research Site | Rotherham | S65 1DA | 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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