A Phase 3 interventional study of Lenbelintide and Placebo in Obesity or Overweight and Diabetes Mellitus, Type 2, sponsored by AstraZeneca. Recruiting at 230 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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
This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Significant hepatobiliary disease and/or any of the following results at Screening:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AZD6234 Dose 1
Drug: Lenbelintide
AZD6234 Dose 2
Drug: Lenbelintide
Matching placebo
Drug: Placebo
IMP injected subcutaneously, once a week. Unit dose strength as per CSP.
Also known as: AZD6234
Placebo matching IMP dose injected subcutaneously, once a week.
Percent change in body weight from baseline at 68 weeks of treatment.
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
Time frame: 68 weeks
Absolute change in weight (kg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on absolute change in weight
Time frame: 68 weeks
Achievement of at least 5 % body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 5%
Time frame: 68 weeks
Achievement of at least 10 % body weight loss from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo in body weight loss of at least 10%
Time frame: 68 weeks
Change in haemoglobin A1C from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 on haemoglobin A1C change
Time frame: 68 weeks
Change in waist circumference (cm) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on waist circumference change
Time frame: 68 weeks
Percent change in triglycerides from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on triglycerides percent change
Time frame: 68 weeks
Change in systolic blood pressure (mmHg) from baseline at 68 weeks of treatment
To evaluate the effect of AZD6234 compared to placebo on systolic blood pressure change
Time frame: 68 weeks
Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA in the DXA Sub-Study subset
Body Composition Sub-study: To evaluate the effect of AZD6234 compared to placebo on body composition change in the DXA subset of participants
Time frame: 68 weeks
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 230 sites across 16 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Lenbelintide