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Lenbelintide

Phase 3

Obesity or Overweight | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Sep 25, 2026

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Aug 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

Lenbelintide · 1 trial · 3 indications

Phase 3 1
NCT07776509A 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 MellitusObesity or Overweight
RECRUITING500 Analytics
PHASE3RECRUITING
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
Obesity or Overweight
NCT07776509500
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Study Endpoints

Primary Endpoints

Percent change in body weight from baseline at 68 weeks of treatment
68 weeks

To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change

Secondary Endpoints

Percent change in body weight from baseline at 68 weeks of treatment
68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
68 weeks
Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment
68 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD6234EXPERIMENTALAZD6234
PlaceboPLACEBO_COMPARATORMatching placebo

Interventions

NameTypeDescription
LenbelintideDRUGIMP injected subcutaneously, once a week.
PlaceboDRUGPlacebo matching IMP dose injected subcutaneously, once a week.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites96

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 f...

Countries:United StatesArgentinaBrazilCanadaChinaDenmarkIsraelJapanSwedenTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

MEDIUMSep 25, 2026NCT07776509lastUpdatePostDate: changed
MEDIUMSep 25, 2026NCT07776509lastUpdatePostDate: changed
LOWSep 10, 2026NCT07776509Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 10, 2026NCT07776509Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07776509NEW_TRIAL: changed
LOWAug 20, 2026NCT07776509NEW_TRIAL: changed

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