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 · 11 trials · 11 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
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
To assess the effect of multiple doses of AZD6234, multiple doses of co-administered AZD9550 and AZD6234, and multiple doses of AZD9550 on the PK of single doses of CoC EE/LEVO.
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
The safety and tolerability of repeated subcutaneous (SC) doses of AZD6234 compared to placebo will be assessed.
The safety and tolerability of AZD6234 following subcutaneous and/or intravenous administration of single ascending doses in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
| 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. |
| Cohort-1: AZD6234 + EE/LEVO + Acetaminophen (APAP) | EXPERIMENTAL | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration. |
| Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP | EXPERIMENTAL | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X1) and AZD9550 (up to a maximum dose of Dose Y1) administration. |
| Cohort-3: AZD9550 + EE/LEVO + APAP | EXPERIMENTAL | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD9550 administration. |
| Cohort-4: AZD6234+AZD9550+EE/LEVO+APAP | EXPERIMENTAL | All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 (up to a maximum dose of Dose X2) and AZD9550 (up to a maximum dose of Dose Y1) administration. |
| 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 |
| Cohort 1 | EXPERIMENTAL | Participants will receive repeated doses of AZD6234 or placebo via SC injection |
| Cohort 2 | EXPERIMENTAL | Participants will receive repeated doses of AZD6234 or placebo via SC injection |
| Cohort 3 | EXPERIMENTAL | Japanese participants will receive repeated doses of AZD6234 or placebo via SC injection |
| Cohort 4 | EXPERIMENTAL | Japanese participants with childbearing potential will receive repeated doses of AZD6234 or placebo via SC injection. |
| Cohort 5 | EXPERIMENTAL | One dose level for SC administration is planned to be investigated for Japanese participants only |
| Cohort 6 | EXPERIMENTAL | Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection |
| Cohort 7 | EXPERIMENTAL | Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection |
| Cohort 8 | EXPERIMENTAL | Participants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection |
| Name | Type | Description |
|---|---|---|
| AZD6234 | DRUG | IMP injected subcutaneously, once a week. |
| Placebo | DRUG | Placebo matching IMP dose 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. |
| Ethinyl estradiol/Levonorgestrel (EE/LEVO) | DRUG | EE/LEVO will be administered as combined oral tablets. |
| Acetaminophen (APAP) | DRUG | APAP will be administered orally as a solution. |
| Acetaminophen | COMBINATION_PRODUCT | Participants will receive a single dose of acetaminophen as part of a meal |
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 for obesity or overweight, including in people with weight-related comorbidities and in those with type 2 diabetes on a stable GLP-1 receptor agonist. It is also being studied in participants with hepatic impairment. It is in Phase 2 clinical development.
AZD6234 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting multiple clinical trials of this investigational small molecule in metabolic conditions, primarily obesity and overweight.
AZD6234 is in Phase 2 clinical development. Most of its trials are Phase 2 studies, including one completed study in obesity or overweight and two active studies in overweight or obesity with type 2 diabetes and in Chinese participants. One Phase 1 trial is also recruiting.
AZD6234 has four clinical trials. NCT06595238 is a completed Phase 2 study in obesity or overweight with a weight-related comorbidity. NCT06851858 is an active Phase 2 study in overweight or obesity with type 2 diabetes. NCT07017179 is an active Phase 2 platform study in Chinese participants with obesity or overweight. NCT07546760 is a recruiting Phase 1 study in hepatic impairment.
Yes, AZD6234 is also known as AZD6234 Formulation 1, AZD6234 Formulation 2, AZD6234 Formulation 2 (low concentration), and AZD6234 Formulation 3. These names refer to different formulations of the same investigational drug being studied by AstraZeneca.
No, AZD6234 is not FDA approved. It is an investigational drug still in clinical development, with most studies in Phase 2 and one in Phase 1. It has not completed the regulatory approval process, and its safety and efficacy have not been established for any indication.