Obesity or Overweight study: Lenbelintide
Official title A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight
ClinicalTrials.gov ID: NCT07784270
What this study is testing
What is AZD6234?
an investigational once‑weekly injectable medicine being studied as a potential treatment for obesity or overweight in adults
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 aims to find out how well AZD6234 works and how safe it is by measuring changes in body weight over about 68 weeks.
- Who it's for
- Adults who have type 2 diabetes and are overweight or obese.
- What's involved
- Participants will be randomly given AZD6234 or a placebo and will have regular check‑ups and weight measurements during the study.
- Time commitment
- The trial lasts roughly 68 weeks with periodic study visits throughout that time.
- 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 ≥27 kg/m2
- Diagnosed with T2DM ≥90 days prior to Screening
- HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral...
- Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation
You likely can't join if
- Obesity primarily caused by other endocrine disorders
- Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar...
- ALT ≥ 3.0 X ULN
- AST ≥ 3.0 X ULN
- TBL \> 1.5 X ULN (except for cases of known Gilbert's Syndrome)
- Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
See the full eligibility criteria
- Males \& females (inclusive of all gender identities) age ≥18 years
- BMI ≥27 kg/m2
- Diagnosed with T2DM ≥90 days prior to Screening
- HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling)
- Stable body weight (≤5% 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 lifetime
- Obesity primarily caused by other endocrine disorders
- Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening
- ALT ≥ 3.0 X ULN
- AST ≥ 3.0 X ULN
- TBL \> 1.5 X ULN (except for cases of known Gilbert's Syndrome)
- Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation
- Use of insulin therapy for T2DM within 3 months prior to screening
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Phoenix, Arizona, United States
- Gardena, California, United States
- Lincoln, California, United States
- Ocoee, Florida, United States
- Woodstock, Georgia, United States
- Lenexa, Kansas, United States
- Franklin, Tennessee, United States
- Houston, Texas, United States
- Norfolk, Virginia, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Ciudad de Buenos Aires, Argentina
- Mendoza, Argentina
- Rosario, Argentina
- Botany, Australia
- Camberwell, Australia
- Charlestown, Australia
- Helensvale, Australia
- Maroubra, Australia
+ 32 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, but 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?
This study is enrolling now at Fairhope, Alabama, United States; Phoenix, Arizona, United States; Gardena, California, United States; Lincoln, California, United States; Ocoee, Florida, United States; Woodstock, Georgia, United States and 46 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.