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NCT06579092CompletedPhase 2

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

A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living With Obesity or Overweight With Comorbidity

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
310 (actual)
First submitted
28 Aug 2024
Start date
8 Oct 2024
Primary completion date
21 Nov 2025
Lead sponsor
AstraZeneca
Diseases
Obesity
NCT number
NCT06579092
EU CT number
2024-513691-18-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 310
  • From 8 Oct 2024 to the primary completion date, 21 Nov 2025
  • 60 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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HeidelbergAustraliaUnknown status
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MerewetherAustraliaUnknown status
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St AlbansAustraliaUnknown status
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St LeonardsAustraliaUnknown status
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CalgaryCanadaUnknown status
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GuelphCanadaUnknown status
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HalifaxCanadaUnknown status
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HamiltonCanadaUnknown status
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SurreyCanadaUnknown status
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TerrebonneCanadaUnknown status
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TorontoCanadaUnknown status
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VictoriaCanadaUnknown status
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
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Bad OeynhausenGermanyCompleted
Velocity Clinical Research GmbH
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BerlinGermanyCompleted
Gemeinschaftspraxis für Innere Medizin und Diabetologie
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HamburgGermanyCompleted
CRS Clinical Research Services Management GmbH
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MannheimGermanyCompleted
Institut fuer Diabetesforschung Muenster GmbH
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MuensterGermanyCompleted
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
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Oldenburg in HolsteinGermanyCompleted
Zentrum für Klinische Studien GmbH
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St IngbertGermanyCompleted
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BlackpoolUnited KingdomUnknown status
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BristolUnited KingdomUnknown status
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ChesterfieldUnited KingdomUnknown status
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LeicesterUnited KingdomUnknown status
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RotherhamUnited KingdomUnknown status
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WitneyUnited KingdomUnknown status
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Suita-shiJapanUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaichungTaiwanUnknown status
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TainanTaiwanUnknown status
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TaipeiTaiwanUnknown status
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AustinUnited StatesUnknown status
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BeachwoodUnited StatesUnknown status
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ChandlerUnited StatesUnknown status
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CharlottesvilleUnited StatesUnknown status
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ChesterfieldUnited StatesUnknown status
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CincinnatiUnited StatesUnknown status
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DallasUnited StatesUnknown status
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DurhamUnited StatesUnknown status
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FargoUnited StatesUnknown status
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Farmington HillsUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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HoustonUnited StatesUnknown status
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Huntington ParkUnited StatesUnknown status
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KnoxvilleUnited StatesUnknown status
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La MesaUnited StatesUnknown status
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LincolnUnited StatesUnknown status
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LombardUnited StatesUnknown status
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ManassasUnited StatesUnknown status
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North CharlestonUnited StatesUnknown status
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OgdenUnited StatesUnknown status
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OmahaUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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RoslindaleUnited StatesUnknown status
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SpartanburgUnited StatesUnknown status
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ValparaisoUnited StatesUnknown status
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VestalUnited StatesUnknown status
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Walnut CreekUnited StatesUnknown status
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West Des MoinesUnited StatesUnknown status
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WilmingtonUnited StatesUnknown status
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WoodwayUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.