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 in people with or without type 2 diabetes who are living with obesity and overweight, as well as in healthy participants in early-stage trials.
AZD9550 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials of AZD9550 as a monotherapy and in combination with another investigational drug, AZD6234, for weight management and related metabolic conditions.
AZD9550 is in clinical development, with trials listed as Phase 1 and Phase 2. The Phase 1 trials assess safety, tolerability, and pharmacokinetics, while a Phase 2 trial evaluates weight loss with AZD9550 alone and in combination with AZD6234. It is not yet approved and remains investigational.
AZD9550 has been studied in several clinical trials. NCT05848440 is a completed Phase 1 single ascending dose study in healthy participants with non-alcoholic steatohepatitis. NCT06151964 is an active Phase 1 trial of AZD9550 alone and with AZD6234 in people with or without type 2 diabetes who are overweight or obese. NCT06862791 is a completed Phase 2 weight loss study comparing AZD9550 and AZD6234 in combination against placebo or each drug alone.
Yes, AZD9550 is being studied in combination with AZD6234, another investigational drug. Clinical trials evaluate AZD9550 monotherapy and combined with AZD6234 in people with or without type 2 diabetes who are living with obesity and overweight, as well as in a weight loss study comparing the combination against placebo or each drug alone.
AZD9550 clinical trials are randomized, double-blind, and controlled. The trials have enrolled a total of 377 participants across studies, with individual trial enrollments of 48, 166, and 377 participants. The studies include healthy volunteers and people with obesity or overweight, with or without type 2 diabetes, across multiple countries.