Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD6234 · 8 trials · 8 indications
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 (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. |
| AZD6234 | EXPERIMENTAL | Weekly SC injections of AZD6234 |
| 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 | Participants will receive a subcutaneous injection weekly |
| Placebo | DRUG | Participants will receive a subcutaneous injection weekly. |
| 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: 1. Age 18 to 55 years. 2. BMI ≥ 27 kg/m2. 3. Stable body weight for 3 months prior to screening. 4. Male and female (Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participati...