Clinical trial
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
Opening soon · Phase 3 · 7 countries · Registry ID NCT07776509
Opening soonPhase 3Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity or Overweight, Weight-Related Comorbidity, With/Without Diabetes Mellitus, Type 2
Full registry criteria
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
Treatments and study arms
AZD6234
Drug
IMP injected subcutaneously, once a week.
Placebo
Drug
Placebo matching IMP dose injected subcutaneously, once a week.
Primary outcomes
Percent change in body weight from baseline at 68 weeks of treatment68 weeks
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change
Study locations
88 locations were listed when this page was built. The first 40 are shown.
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 CABA, Argentina
Research Site🇦🇷 Ciudad de Buenos Aires, Argentina
Research Site🇦🇷 Ciudad de Buenos Aires, Argentina
Research Site🇦🇷 Rosario, Argentina
Research Site🇦🇷 San Nicolás, Argentina
Research Site🇧🇷 Belo Horizonte, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 Campinas, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🇧🇷 São Paulo, Brazil
Research Site🇨🇦 Calgary, Alberta, Canada
Research Site🇨🇦 Calgary, Alberta, Canada
Research Site🇨🇦 Guelph, Ontario, Canada
Research Site🇨🇦 Hamilton, Ontario, Canada
Research Site🇨🇦 Joliette, Quebec, Canada
Research Site🇨🇦 Montreal, Quebec, Canada
Research Site🇨🇦 Stouffville, Ontario, Canada
Research Site🇨🇦 Surrey, British Columbia, Canada
Research Site🇨🇦 Toronto, Ontario, Canada
Research Site🇨🇦 Vancouver, British Columbia, Canada
Research Site🇨🇳 Nanjing, China
Research Site🇨🇳 Nanjing, China
Research Site🇨🇳 Ningbo, China
Research Site🇩🇰 Aarhus N, Denmark
Research Site🇩🇰 Gandrup, Denmark
Research Site🇩🇰 Herlev, Denmark
Research Site🇩🇰 Holbæk, Denmark
Research Site🇩🇰 Hvidovre, Denmark
Research Site🇩🇰 Odense, Denmark
Research Site🇩🇰 Vejle, Denmark
Research Site🇮🇱 Holon, Israel
Research Site🇮🇱 Jerusalem, Israel
Research Site🇮🇱 Kfar Saba, Israel
Research Site🇮🇱 Petah Tikva, Israel
Research Site🇮🇱 Petah Tikva, Israel
Research Site🇮🇱 Tel Aviv, Israel
Research Site🇯🇵 Chūōku, Japan
Research Site🇯🇵 Ichinomiya-shi, Japan