Clinical trial for Obesity or Overweight
Official title 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
ClinicalTrials.gov ID: NCT07776509
What this study is testing
What is AZD6234?
AZD6234 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity or overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Lincoln, California, United States
- Walnut Creek, California, United States
- Jacksonville, Florida, United States
- Stockbridge, Georgia, United States
- Woodstock, Georgia, United States
- Champaign, Illinois, United States
- Chicago, Illinois, United States
- Beltsville, Maryland, United States
- Oxon Hill, Maryland, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
- Somerset, New Jersey, United States
- Statesville, North Carolina, United States
- Fargo, North Dakota, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Smithfield, Pennsylvania, United States
- Franklin, Tennessee, United States
- Houston, Texas, United States
+ 65 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Escondido, California, United States; Lincoln, California, United States; Walnut Creek, California, United States; Jacksonville, Florida, United States; Stockbridge, Georgia, United States; Woodstock, Georgia, United States and 79 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.