A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus

Recruiting · NCT07776509 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Males \& females (inclusive of all gender identities) age ≥18 years
BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence
For participants with T2DM only:
Diagnosed with T2DM ≥ 90 days prior to Screening
HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication
Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.
Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation
History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime

Exclusion criteria

Obesity primarily caused by other endocrine disorders
Type 1 diabetes mellitus
Significant hepatobiliary disease and/or any of the following results at Screening:
ALT ≥ 3.0 × ULN
AST ≥ 3.0 × ULN
TBL \> 1.5 × ULN (except for cases of known Gilbert's Syndrome)
Use of insulin therapy for T2DM within 3 months prior to screening

Where it is running

60 locations listed across 17 US states.

Research Site - Escondido, California, United States
Research Site - Lincoln, California, United States
Research Site - Walnut Creek, California, United States
Research Site - Fleming Island, Florida, United States
Research Site - Jacksonville, Florida, United States
Research Site - Stockbridge, Georgia, United States
Research Site - Woodstock, Georgia, United States
Research Site - Champaign, Illinois, United States
Research Site - Chicago, Illinois, United States
Research Site - Beltsville, Maryland, United States
Research Site - Oxon Hill, Maryland, United States
Research Site - Kansas City, Missouri, United States
Research Site - Las Vegas, Nevada, United States
Research Site - Somerset, New Jersey, United States
Research Site - Statesville, North Carolina, United States
Research Site - Fargo, North Dakota, United States
Research Site - Columbus, Ohio, United States
Research Site - Portland, Oregon, United States
Research Site - Smithfield, Pennsylvania, United States
Research Site - Franklin, Tennessee, United States
Research Site - Houston, Texas, United States
Research Site - Manassas, Virginia, United States
Research Site - Renton, Washington, United States
Research Site - Aarhus N, Denmark
Research Site - Airdrie, United Kingdom
Research Site - Ankara, Turkey (Türkiye)
Research Site - Ankara, Turkey (Türkiye)
Research Site - Antalya, Turkey (Türkiye)
Research Site - Beijing, China
Research Site - Belo Horizonte, Brazil
Research Site - Buenos Aires, Argentina
Research Site - CABA, Argentina
Research Site - Campinas, Brazil
Research Site - Campinas, Brazil
Research Site - Center, Turkey (Türkiye)
Research Site - Changchun, China
Research Site - Chengdu, China
Research Site - Chengdu, China
Research Site - Chippenham, United Kingdom
Research Site - Chūōku, Japan
Research Site - Ciudad de Buenos Aires, Argentina
Research Site - Gandrup, Denmark
Research Site - Guangzhou, China
Research Site - Herlev, Denmark
Research Site - Herlev, Denmark
Research Site - Holbæk, Denmark
Research Site - Holon, Israel
Research Site - Hull, United Kingdom
Research Site - Huzhou, China
Research Site - Hvidovre, Denmark
Research Site - Ichinomiya-shi, Japan
Research Site - Istanbul, Turkey (Türkiye)
Research Site - Izunokuni-shi, Japan
Research Site - Jerusalem, Israel
Research Site - Kamakura-shi, Japan
Research Site - Kawagoe-shi, Japan
Research Site - Kfar Saba, Israel
Research Site - Kitakyushu-shi, Japan
Research Site - Kyoto, Japan
Research Site - Kyoto, Japan

Showing 60 of 96 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →