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Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity

PHASE2RECRUITING

A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity.

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Study details:

This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Adults ≥ 18 years of age.

BMI of (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).

Exclusion criteria

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 type 2 diabetes mellitus.

Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.

History of acute or chronic pancreatitis.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-10-08

Primary completion: 2025-12-04

Study completion finish: 2025-12-04

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT06579092

Intervention or treatment

DRUG: AZD5004

DRUG: Placebo

Conditions

• Obesity or Overweight

Condition: Obesity or Overweight
DRUG: AZD5004 and other drugs
St Albans, Not Specified, Australia
Sponsor: AstraZeneca

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Research Site

Research sites nearby

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Research Site
St Albans, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm 1 Active IMP	DRUG: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks
EXPERIMENTAL: Arm 2 Active IMP	DRUG: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks
EXPERIMENTAL: Arm 3 Active IMP	DRUG: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks
EXPERIMENTAL: Arm 4 Active IMP	DRUG: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks
EXPERIMENTAL: Arm 5 Active IMP	DRUG: AZD5004 AZD5004 film-coated tablet once daily during 36 weeks
PLACEBO_COMPARATOR: Arm 6 Matching placebo for each of the 5 active arms	DRUG: Placebo Placebo matching AZD5004 film-coated tablet once daily during 36 weeks

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Percent change in body weight from baseline	To determine whether AZD5004 is superior to placebo for weight loss	26 weeks
Proportion of participants with weight loss ≥ 5% from baseline weight	To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline	26 weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Percent change in body weight from baseline	To determine whether AZD5004 is superior to placebo for weight loss	36 weeks
Proportion of participants with weight loss ≥ 5%	To determine whether AZD5004 is superior to placebo on the proportion of participants with weight loss ≥ 5% from baseline	36 weeks
Absolute change from baseline in body weight	To determine whether AZD5004 is superior to placebo for absolute weight loss	Week 26 and Week 36
Proportion of participants with weight loss ≥ 10% as well as ≥ 15%	To assess the effect of AZD5004 versus placebo on the proportion of participants with weight loss ≥ 10% as well as ≥ 15%	Week 26 and Week 36

Frequently Asked Questions

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References

Clinical Trials Gov: Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity