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Effects of AZD5004 in adults who are living with obesity or overweight with at least 1 weight-related medical condition
EU CTIS ID: 2024-513691-18-00
What this study is testing
To determine whether AZD5004 is superior to placebo for weight loss at 26 weeks To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline at week 26
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Be at least 18 years old at the time of signing the informed consent.
- At Screening, have a BMI: (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated): (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
- A stable body weight for 3 months prior to Screening (± 5% body weight change)
- Capable of giving signed informed consent
- Female(s) of childbearing potential (FOCBP): − Must use adequate contraception from enrollment, through the study, after the last dose of IMP. − Oral contraceptives are not permitted
- Female(s) not of childbearing potential
You likely can't join if
- Have obesity induced by other endocrine disorders, such as Cushing’s syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome
- Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
- Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
- History of type 1 diabetes mellitus or T2DM
- Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
- Treatment with diabetes medication in past 3 months prior to Screening
See the full eligibility criteria
- Be at least 18 years old at the time of signing the informed consent.
- At Screening, have a BMI: (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated): (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
- A stable body weight for 3 months prior to Screening (± 5% body weight change)
- Capable of giving signed informed consent
- Female(s) of childbearing potential (FOCBP): − Must use adequate contraception from enrollment, through the study, after the last dose of IMP. − Oral contraceptives are not permitted
- Female(s) not of childbearing potential
- Male participants: − Condom use is required for the duration of the trial after the last dose of IMP − Additional contraception must be used for the sexual partners of male trial participants throughout the clinical trial following the last dose of IMP
- Have obesity induced by other endocrine disorders, such as Cushing’s syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome
- Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
- Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
- History of type 1 diabetes mellitus or T2DM
- Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
- Treatment with diabetes medication in past 3 months prior to Screening
- Cardiac arrhythmia or electrocardiogram (ECG) morphology abnormalities, as considered by the investigator, that may interfere with interpretation of QT interval corrected for heart rate (QTc) interval changes, including ST wave morphology
- Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract
- History of psychosis or bipolar disorder
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
- Japan
- United Kingdom
- United States
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada; Japan; United Kingdom; United States; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.