Obesity or Overweight study: Lenbelintide
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 Lenbelintide?
This is an investigational once-weekly injectable medicine being studied as a potential treatment for obesity or overweight.
Also referred to as AZD6234.
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
- This study aims to find out if adding AZD6234 to standard weight-loss treatments leads to greater weight loss and is safe for participants.
- Who it's for
- Adults who have obesity or are overweight and have health problems related to their weight, with or without type 2 diabetes.
- What's involved
- Participants will take AZD6234 or a placebo (a pill with no active medicine) along with their usual incretin-based weight-loss therapies and undergo regular health checks.
- Time commitment
- The study lasts 68 weeks and requires regular visits to the clinic for monitoring and testing.
- 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...
- 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...
- 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...
You likely can't join if
- Obesity primarily caused by other endocrine disorders
- Type 1 diabetes mellitus
- 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
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...
- 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
- 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 is enrolling
- Lincoln, California, United States
- Stockbridge, Georgia, United States
- Woodstock, Georgia, United States
- Champaign, Illinois, United States
- Chicago, Illinois, United States
- Kansas City, Missouri, United States
- Statesville, North Carolina, United States
- Fargo, North Dakota, United States
- Columbus, Ohio, United States
- Smithfield, Pennsylvania, United States
- Houston, Texas, United States
- Buenos Aires, Argentina
- CABA, Argentina
- Ciudad de Buenos Aires, Argentina
- Rosario, Argentina
- Campinas, Brazil
- Calgary, Alberta, Canada
- Surrey, British Columbia, Canada
- Vancouver, British Columbia, Canada
- Guelph, Ontario, Canada
+ 34 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 Lincoln, California, United States; Stockbridge, Georgia, United States; Woodstock, Georgia, United States; Champaign, Illinois, United States; Chicago, Illinois, United States; Kansas City, Missouri, United States and 48 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.