Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD6234 Formulation 1, AZD6234 Formulation 2 (low concentration), AZD6234 Formulation 2, AZD6234 Formulation 3, AZD6234 Formulation 2 (high concentration), Lenbelintide
AZD6234 · 8 trials · 10 indications
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 | EXPERIMENTAL | AZD6234 |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| 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 |
|---|---|---|
| Lenbelintide | DRUG | IMP injected subcutaneously, once a week. |
| Placebo | DRUG | Placebo matching IMP dose injected subcutaneously, once a week. |
| AZD6234 | DRUG | IMP injected subcutaneously, once a week. Unit dose strength as per CSP. |
| 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: * 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...
AZD6234 is an investigational small molecule being developed by AstraZeneca for metabolic conditions, including obesity or overweight, type 2 diabetes with obesity or overweight, and hepatic impairment. It is in clinical development and has not been approved by the FDA. It is studied in randomized, double-blind, placebo-controlled trials.
AZD6234 is being studied for the treatment of adults with obesity or overweight, including people with weight-related comorbidities and people with type 2 diabetes mellitus and obesity or overweight. It is also being evaluated in adults with hepatic impairment. These uses remain investigational and are not approved.
AZD6234 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsors the clinical program, including the Phase 3 obesity studies and the Phase 1 hepatic impairment study of AZD6234.
AZD6234 is in Phase 2 and Phase 3 clinical development. Two Phase 3 trials in obesity or overweight are recruiting, and a Phase 2 platform study in Chinese participants with obesity or overweight is active but not recruiting. AZD6234 is investigational and has not been approved by the FDA.
AZD6234 is being studied in NCT07784725, a Phase 3 trial in adults with obesity or overweight and weight-related comorbidity without type 2 diabetes, and NCT07784270, a Phase 3 trial in adults with type 2 diabetes and obesity or overweight. NCT07017179 is a Phase 2 platform study in China, and NCT07546760 is a Phase 1 hepatic impairment study.
Yes. AZD6234 Formulation 1, AZD6234 Formulation 2, AZD6234 Formulation 2 (low concentration), and AZD6234 Formulation 3 are alternative names for AZD6234. These refer to different formulations of the same investigational small molecule developed by AstraZeneca.