Effects of AZD5004 in adults who are living with obesity or overweight with at least 1 weight-related medical condition

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

11 Dec 2024 → 21 Nov 2025

Decision date (initial)

2024-10-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Astrazeneca

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Safety, Dose response

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

Secondary objectives 4

1. To determine whether AZD5004 is superior to placebo for weight loss at 36 weeks
2. To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline at 36 weeks
3. To determine whether AZD5004 is superior to placebo for absolute weight loss
4. To assess the effect of AZD5004 versus placebo on the proportion of participants with weight loss ≥ 10% as well as ≥ 15%

Conditions and MedDRA coding

Participants living with Obesity or Overweight with at least 1 comorbidity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Be at least 18 years old at the time of signing the informed consent.
2. 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
3. A stable body weight for 3 months prior to Screening (± 5% body weight change)
4. Capable of giving signed informed consent
5. 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
6. Female(s) not of childbearing potential
7. 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

Exclusion criteria 9

1. Have obesity induced by other endocrine disorders, such as Cushing’s syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome
2. Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
3. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
4. History of type 1 diabetes mellitus or T2DM
5. Hemoglobin A1c (HbA1c) ≥ 6.5% (48 mmol/mol) at Screening
6. Treatment with diabetes medication in past 3 months prior to Screening
7. 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
8. Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract
9. History of psychosis or bipolar disorder

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Percent change in body weight from baseline at Week 26
2. Proportion of participants with weight loss ≥ 5% from baseline weight at Week 26

Secondary endpoints 4

1. Percent change in body weight from baseline at Week 36
2. Proportion of participants with weight loss ≥ 5% at Week 36
3. Absolute change from baseline in body weight at Week 26 and at Week 36
4. Proportion of participants with weight loss ≥ 10% as well as ≥ 15% at Week 26 and at Week 36

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications