Actively Recruiting
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Led by AstraZeneca · Updated on 2026-05-12
160
Participants Needed
15
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
AZD9550, previously being developed for the treatment NASH, is a dual GCG and GLP-1 receptor agonist. AZD9550 is now being developed in combination with AZD6234, a SARA, for the treatment of overweight and obesity and its associated co-morbidities. Co-administration of AZD9550 and AZD6234 is currently being evaluated in participants living with obesity and overweight without T2DM in an ongoing Phase 2b study. The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 monotherapy 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 (Parts A-D). In addition, the study will investigate the safety and tolerability of co-administration of AZD9550 and AZD6234 in participants living with T2DM with obesity or overweight aged 18 through 75 years (Part E), and safety and tolerability for different titration regimens for AZD9550 in participants living with obesity, but without T2DM, aged 18 through 75 years (Part F).
CONDITIONS
Official Title
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 through 65 years (Parts A-D) or up to 75 years (Parts E-F) at screening
- Participants with or without type 2 diabetes (T2DM) in Parts A, B, C; with specific glucose control and treatment conditions
- Participants diagnosed with T2DM with inadequate glycaemic control or treated with diet, exercise, or oral anti-diabetic agents as specified in Parts D and E
- Screening HbA1c within 6% to 10% (Parts A to E) or less than 6.5% (Part F)
- Body mass index (BMI) from 27 to 39.9 kg/m2 (Parts A-C) or 27 kg/m2 or higher (Part E), or 30 kg/m2 or higher (Part F)
- Use of contraception consistent with local regulations
- Written informed consent and authorization obtained before any study procedures
- Ability to complete eligibility requirements within 60 days after consent
- Suitable venous access for multiple blood draws
- Willing and able to receive weekly subcutaneous injections (Parts C, D, E, and F)
You will not qualify if you...
- Participants with T2DM treated with insulin (Parts A-E) or treated with more than 3 anti-diabetic therapies (Parts A-D)
- Treatment with GLP-1 receptor agonists or similar drugs within specified timeframes
- History of major diseases or conditions that increase risk or affect study participation
- Elevated serum calcitonin or history/family history of certain thyroid conditions
- History or presence of significant gastrointestinal, renal, hepatic diseases (except Gilbert's syndrome)
- History of cancer within last 10 years (except non-melanoma skin cancer)
- Clinically important illnesses or medical/surgical procedures within 4 weeks prior to screening
- Symptoms of poorly controlled diabetes
- Positive hepatitis B, hepatitis C, or HIV tests
- Abnormal lab values above specified thresholds
- Impaired renal function below defined eGFR levels
- Abnormal vital signs or ECGs, presence of cardiac devices or arrhythmias
- Recent severe cardiac events or heart failure
- History of drug abuse, severe allergies, psychiatric disorders or unstable depression
- Recent blood donation or significant blood loss
- Use of systemic corticosteroids, weight loss drugs, or enzyme-inducing drugs within specified periods
- Participation in other clinical studies recently or concurrently
- Ongoing weight loss diet or use of weight loss agents within 3 months
- Vegan or medically restricted diets likely to increase ketones (Parts A-D)
- Excessive caffeine intake or recent smoking/nicotine use (Parts A-D)
- Inability to communicate reliably or vulnerable participant status
- Employment or close relation to study sponsor or staff
- Contraindications to MRI (Parts B and C)
- High serum triglycerides or recent marijuana/THC use (Parts E and F)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Research Site
Graz, Austria, 8036
Completed
2
Research Site
Vienna, Austria, 1090
Completed
3
Research Site
Surrey, British Columbia, Canada, V3T 4G8
Actively Recruiting
4
Research Site
Hamilton, Ontario, Canada, L8L 5G8
Actively Recruiting
5
Research Site
Sarnia, Ontario, Canada, N7T 4X3
Actively Recruiting
6
Research Site
Stouffville, Ontario, Canada, L4A 1H2
Actively Recruiting
7
Research Site
Toronto, Ontario, Canada, M4G 3E8
Actively Recruiting
8
Research Site
Sherbrooke, Quebec, Canada, J1L 0H8
Completed
9
Research Site
Magdeburg, Germany, 39120
Active, Not Recruiting
10
Research Site
Neu-Ulm, Germany, 89231
Active, Not Recruiting
11
Research Site
Neuss, Germany, 41460
Active, Not Recruiting
12
Research Site
Fukuoka, Japan, 812-0025
Completed
13
Research Site
Shinjuku-ku, Japan, 160-0004
Completed
14
Research Site
Suita-shi, Japan, 565-0853
Completed
15
Research Site
Uppsala, Sweden, 752 37
Completed
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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