Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD6234
Lenbelintide · 9 trials · 12 indications
To evaluate the effect of AZD6234 as compared to placebo in percent body weight change from baseline of treatment.
To evaluate the effect of AZD6234 as compared to placebo in body weight loss of at least 5% from baseline of treatment.
To evaluate the effect of AZD6234 as compared to placebo as an adjunct to incretin-based therapies in percent body weight change
To evaluate the effect of AZD6234 compared to placebo in percent body weight change
To assess the safety and tolerability of repeated subcutaneous(SC) doses of AZD6234 compared to placebo.
To assess the safety and tolerability of repeated SC doses of AZD9550 and AZD6234 in combination with AZD9550 compared to placebo.
To determine whether treatment with AZD6234 is superior to placebo for weight loss at Study Week 26
To assess the effect of AZD6234 versus placebo on the proportion of participants with weight loss ≥ 5% from baseline at Study Week 26
To determine whether AZD6234 is superior to placebo for weight loss
To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline
To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
To compare the plasma PK of separate single SC doses of AZD9550 and AZD6234 in participants with severe and moderate hepatic impairment with matched controls with normal hepatic function
Area under plasma concentration-time curve from time zero to the last measurable concentration
Area under plasma concentration-time curve from zero to infinity
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| AZD6234 Higher Target-Dose | EXPERIMENTAL | Participants will receive AZD6234 with dose titration to the higher target dose, followed by a safety follow-up period. |
| AZD6234 Lower Target-Dose | EXPERIMENTAL | Participants will receive AZD6234 with dose titration to the lower target dose, followed by a safety follow-up period. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo with dose titration according to the protocol, followed by a safety follow-up period. |
| AZD6234 | EXPERIMENTAL | AZD6234 |
| AZD6234 Dose 1 | EXPERIMENTAL | AZD6234 Dose 1 |
| AZD6234 Dose 2 | EXPERIMENTAL | AZD6234 Dose 2 |
| AZD6234 (sub-study 1) | EXPERIMENTAL | Participants will receive subcutaneous injection of AZD6234 on Day 1 and continue for 16 weeks. |
| Placebo (sub-study 1) | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 16 weeks. |
| AZD9550（sub-study 2 Cohort A) | EXPERIMENTAL | Participants will receive subcutaneous injection of AZD9550 on Day 1 and continue for 28 weeks. |
| Placebo (sub-study 2 Cohort A) | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks. |
| AZD6234 in combination with AZD9550 (sub-study 2 Cohort B) | EXPERIMENTAL | Participants will receive subcutaneous injection of AZD6234 and AZD9550 on Day 1 and continue for 28 weeks. |
| Placebo (sub-study 2 Cohort B) | PLACEBO_COMPARATOR | Participants will receive subcutaneous injection of matched volume of placebo on Day 1 and continue for 28 weeks. |
| Placebo for AZD6234 | PLACEBO_COMPARATOR | Weekly SC injections of matching placebo |
| Arm 1 | EXPERIMENTAL | Dose 1 |
| Arm 2 | EXPERIMENTAL | Dose 2 |
| Arm 3 | EXPERIMENTAL | Dose 3 |
| Arm 4 | PLACEBO_COMPARATOR | Placebo - Dose matched with each Experimental arm |
| Group 1 | EXPERIMENTAL | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). |
| Group 2 | EXPERIMENTAL | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). |
| Group 3 | EXPERIMENTAL | Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the participants with hepatic impairment. |
| Group 4 (optional) | EXPERIMENTAL | Subjects with moderate renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions |
| Group 5 (optional) | EXPERIMENTAL | Subjects with mild renal impairment will receive a single subcutaneous dose of AZD6234 under fasted conditions |
| Name | Type | Description |
|---|---|---|
| AZD6234 | DRUG | administered once weekly. |
| Placebo | DRUG | Matching placebo administered once weekly. |
| Lenbelintide | DRUG | IMP injected subcutaneously, once a week. |
| AZD9550 | DRUG | Participants will receive a subcutaneous injection weekly |
| Plocebo | DRUG | Participants will receive a subcutaneous injection weekly |
| AZD6234 in combination with AZD9550 | DRUG | Participants will receive a subcutaneous injection weekly |
| Placebo to match | DRUG | Weekly SC injections of matching placebo |
| Placebo comparator | DRUG | Placebo matching IMP dose injected subcutaneously, once a week. |
Inclusion Criteria: * Aged 18 years or older at the time of signing informed consent. * Body mass index: * at least 28 kg/m²; or * at least 24 kg/m² and less than 28 kg/m² with at least one protocol-defined weight-related comorbidity, including type 2 diabetes mellitus, hypertension, dyslipidaemia,...
Lenbelintide is being developed for obesity or overweight, including in adults with weight-related comorbidities and in adults with type 2 diabetes and obesity or overweight. It is also being studied as an adjunct to incretin-based therapies. It is an investigational small molecule in Phase 3 development and has not been approved for any use.
Lenbelintide is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is running the Phase 3 clinical program for the drug in obesity or overweight, including a trial evaluating it as an adjunct to incretin-based therapies.
Lenbelintide is in Phase 3 clinical development. Three Phase 3 trials are active and recruiting, with no completed trials yet. The program is randomized, double-blind, and placebo-controlled, and has enrolled or plans to enroll about 4,500 participants across the three studies.
Lenbelintide is in three recruiting Phase 3 trials: NCT07784725 in adults with obesity or overweight with weight-related comorbidity without type 2 diabetes (2,500 participants), NCT07784270 in adults with type 2 diabetes and obesity or overweight (1,500 participants), and NCT07776509 as an adjunct to incretin-based therapies (500 participants).
No. Lenbelintide is investigational and remains in Phase 3 clinical development, so it is not approved for marketing. Its safety and efficacy in obesity or overweight are still being evaluated in randomized, double-blind, placebo-controlled trials.
The Lenbelintide Phase 3 trials enroll adults aged 18 years and older across multiple countries, including the United States, Canada, Brazil, Argentina, China, Japan, South Korea, Taiwan, Germany, Poland, the United Kingdom, and others. All three studies are currently recruiting participants.