A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 in Overweight and Obese Participants With or Without Type 2 Diabetes Mellitus

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

AZD9550 is in early development for the treatment of NASH, a type of liver disease that commonly affects overweight and obese participants living with or without T2DM. The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 in overweight and obese participants aged 18 through 65 years living with or without T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Males or post-menopausal females aged 18 through 65 years at the time of screening.

• Parts A, B, C only: Participants with or without T2DM. If participants have a diagnosis of T2DM, the glucose control managed with diabetes diet and in addition to metformin treatment no more than two treatment options (with a stable dose 3 months prior to screening).

• Part D only: Participants who are diagnosed with T2DM, have inadequate glycaemic control with diet and exercise. Participants who are prescribed an oral anti-diabetic agent such as metformin, a DPP IV inhibitor, sulphonylurea, glinides, alphaglucosidase inhibitors, and an SGLT2 inhibitor may be eligible to enter the study following a washout of 4-weeks or 5-half lives (whichever is longer) washout period.

• Participants with a screening HbA1c value within the target range of

‣ ≥ 42 to ≤ 75 mmol/mol (6% to 9%) for T2DM patients

⁃ \< 48 mmol/mol (\< 6.5%) for participants without T2DM

• Body mass index from ≥27 (≥25 in Part D) to ≤39.9 kg/m2 (inclusive).

• Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

• Written informed consent and any locally required authorization (eg, European Union Data Privacy Directive) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations

• Ability to complete and meet all eligibility requirements for randomisation within 60 days after signing the ICF.

• Venous access suitable for multiple cannulations.

• Willing and able to self-administer weekly SC injections (Parts C and D only).

Locations
Other Locations
Austria
Research Site
COMPLETED
Graz
Research Site
COMPLETED
Vienna
Canada
Research Site
NOT_YET_RECRUITING
Sarnia
Research Site
NOT_YET_RECRUITING
Sherbrooke
Research Site
NOT_YET_RECRUITING
Stouffville
Research Site
RECRUITING
Surrey
Research Site
RECRUITING
Toronto
Research Site
NOT_YET_RECRUITING
Toronto
Germany
Research Site
RECRUITING
Magdeburg
Research Site
RECRUITING
Neu-ulm
Research Site
RECRUITING
Neuss
Japan
Research Site
COMPLETED
Fukuoka
Research Site
COMPLETED
Shinjuku-ku
Research Site
COMPLETED
Suita-shi
Sweden
Research Site
COMPLETED
Uppsala
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2026-07-24
Participants
Target number of participants: 116
Treatments
Experimental: Part A: AZD9550
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
Experimental: Part B: AZD9550
Once weekly up-titration over 5 doses of AZD9550 in overweight/obese participants with or without T2DM
Experimental: Part C: AZD9550
Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese participants with or without T2DM.
Experimental: Part D: AZD9550
Bi-weekly/monthly up-titration of AZD9550 for 24 weeks in overweight/obese Japanese participants with T2DM (Part D).
Experimental: Part A: placebo
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
Experimental: Part B: placebo
Once weekly up-titration over 5 doses of placebo in overweight/obese participants with or without T2DM
Experimental: Part C: placebo
Bi-weekly/monthly up-titration of placebo for 24 weeks in overweight/obese participants with or without T2DM.
Experimental: Part D: placebo
Bi-weekly/monthly up-titration of placebo for 24 weeks in overweight/obese Japanese participants with T2DM (Part D).
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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