Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9550 · 3 trials · 3 indications
To determine whether treatment with AZD9550 and AZD6234 in combination is superior to placebo for weight loss
To assess the effect of treatment with AZD9550 and AZD6234 in combination vs placebo on the proportion of participants with weight loss ≥ 5%
Applicable for Parts A, B, C, D, E, F.
Applicable for Parts A, B, C, D, E, F.
Applicable for Parts A, B, C, D, E, F.
Applicable for Parts A, B, C, D, E, F.
* AUC from 0 to the time of the last measured concentration (AUClast) at first dose and last dose * AUC over a dosing interval (AUCtau) at first dose and last dose. Applicable for Part A.
• Cmax at first dose and last dose Applicable for Part A.
• t1/2λz at first dose and last dose Applicable for Part A.
• tmax at first dose and last dose Applicable for Part A.
• CL/F at first dose and last dose Applicable for Part A.
• Vz/F at first dose and last dose Applicable for Part A.
• Rac AUCtau at last dose Applicable for Part A.
• Rac Cmax at last dose Applicable for Part A.
The safety and tolerability of AZD9550 following SC administration of single ascending doses to healthy participants, SC administration of a single dose to Japanese participants, and IV administration of a single dose to healthy participants will be assessed.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | AZD9550 low dose + AZD6234 low dose or placebos |
| Arm 2 | EXPERIMENTAL | AZD9550 medium dose + AZD6234 medium dose or placebos |
| Arm 3 | EXPERIMENTAL | AZD9550 high dose + AZD6234 high dose or placebos |
| Arm 4 | EXPERIMENTAL | AZD9550 low dose + AZD6234 medium dose or placebos |
| Arm 5 | EXPERIMENTAL | AZD9550 medium dose + AZD6234 low dose or placebos |
| Arm 6 | EXPERIMENTAL | AZD9550 high dose + AZD6234 medium dose or placebos |
| Arm 7 | EXPERIMENTAL | AZD9550 medium dose + AZD6234 high dose or placebos |
| Arm 8 | EXPERIMENTAL | AZD9550 high dose or placebo |
| Arm 9 | EXPERIMENTAL | AZD6234 high dose or placebo |
| Part A: AZD9550 | EXPERIMENTAL | Multiple repeat doses of AZD9550 given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 |
| Part B: AZD9550 | EXPERIMENTAL | Once weekly up-titration over 5 doses of AZD9550 in overweight/obese participants with or without T2DM |
| Part C: AZD9550 | EXPERIMENTAL | Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese participants with or without T2DM. |
| Part D: AZD9550 | EXPERIMENTAL | Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese Japanese participants with T2DM. |
| Part A: placebo | EXPERIMENTAL | Multiple repeat doses of placebo given as 4 once weekly SC doses for 4 weeks to 2 sequential cohorts in overweight/obese participants with or without T2DM, evaluating 2 low dose levels of AZD9550 |
| Part B: placebo | EXPERIMENTAL | Once weekly administration of placebo over 5 doses, volume matched to the active treatment being up-titrated, in overweight/obese participants with or without T2DM |
| Part C: placebo | EXPERIMENTAL | Bi-weekly/monthly administration of placebo - volume matched to the active treatment being up-titrated - for 24 weeks in overweight/obese participants with or without T2DM. |
| Part D: placebo | EXPERIMENTAL | Bi-weekly/monthly administration of placebo - volume matched to the active treatment being up-titrated - 24 weeks in overweight/obese Japanese participants with T2DM. |
| Part E: AZD9550 and AZD6234 | EXPERIMENTAL | Bi-weekly/monthly up-titration of AZD9550 and AZD6234 for 24 weeks in overweight/obese participants with T2DM. |
| Part E: placebo | EXPERIMENTAL | Bi-weekly/monthly administration of placebo - volume matched to the active treatments being up-titrated - 24 weeks in overweight/obese participants with T2DM. |
| Part F: AZD9550 | EXPERIMENTAL | Bi-weekly/monthly up-titration of AZD9550 for 28 weeks in obese participants without T2DM. |
| Part F: placebo | EXPERIMENTAL | Bi-weekly/monthly administration of placebo - volume matched to the active treatment - 28 weeks in obese participants without T2DM. |
| Part A | EXPERIMENTAL | Participants will be administered single ascending SC doses of AZD9550 or a placebo. |
| Part B | EXPERIMENTAL | Participants will be administered one SC dose of AZD9550 or a placebo. |
| Part C | EXPERIMENTAL | Participants will be administered one IV dose of AZD9550 or a placebo. |
| Name | Type | Description |
|---|---|---|
| AZD9550 | DRUG | IMP injected subcutaneous, once weekly. Unit dose strength as per CSP |
| AZD6234 | DRUG | IMP injected subcutaneous, once weekly. Unit dose strength as per CSP. |
| Placebo comparator | DRUG | Placebo matching IMP dose injected subcutaneously, once weekly. |
| placebo | DRUG | Matching administration volumes for SC injection. For Part E placebo two injections of two different placebos. |
| AZD9550 and AZD6234 | DRUG | Part E: Doses of AZD9550 and AZD6234 that increase every 2 weeks, then every 4 weeks |
Inclusion Criteria: * Participant must be 18 to 75 years of age inclusive. * BMI: ≥ 30 kg/m2, or ≥ 27 kg/m2 with at least one weight related comorbidity. * A stable, self-reported body weight for 3 months prior to screening. * Male and female participants: Contraceptive use by males or females shou...
AZD9550 is an investigational small molecule being developed for metabolic conditions, including overweight and obesity, and non-alcoholic steatohepatitis (NASH). It is being studied as a monotherapy and in combination with AZD6234 for weight loss in people with or without type 2 diabetes who are living with obesity and overweight.
AZD9550 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug.
AZD9550 is in clinical development, with trials listed as Phase 1 and Phase 2. It is an investigational drug, meaning it has not been approved by regulatory authorities. The studies are assessing its safety, tolerability, pharmacokinetics, and weight loss effects in various patient populations.
AZD9550 has been studied in several clinical trials, including NCT05848440, a Phase 1 single ascending dose study in healthy participants with NASH, and NCT06151964, a Phase 1 trial in people with obesity and overweight. NCT06862791 is a Phase 2 weight loss study evaluating AZD9550 alone and in combination with AZD6234.
AZD9550 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its effects on metabolic conditions such as obesity and NASH, and clinical trials are evaluating its safety and efficacy in these indications.
No, AZD9550 and AZD6234 are different investigational drugs. They are being studied together in clinical trials, such as NCT06151964 and NCT06862791, to assess the safety and efficacy of AZD9550 as a monotherapy and in combination with AZD6234 for weight loss in people with obesity and overweight.