Actively Recruiting
A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 Alone and With AZD6234 in Adults Living With Obesity and Overweight With or Without Type 2 Diabetes Mellitus
Led by AstraZeneca · Updated on 2026-05-12
160
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD9550, a dual GCG and GLP-1 receptor agonist, alone and in combination with AZD6234, a selective androgen receptor antagonist (SARA), for safety, tolerability, and effects in adults living with overweight or obesity, with or without type 2 diabetes mellitus (T2DM). This Phase I/II randomized, single-blind, placebo-controlled study includes participants aged 18 to 65 or up to 75 years depending on study part and aims to understand how AZD9550 is processed in the body and its impact on metabolic parameters. The study involves multiple parts assessing AZD9550 given in various dosing schedules, including constant doses, weekly dose increases, and bi-weekly or monthly dose escalations over periods up to 28 weeks. Some parts evaluate AZD9550 alone, while another part examines co-administration of AZD9550 and AZD6234 in participants with T2DM. Placebo groups receive volume-matched injections to compare safety and tolerability. Dosing is administered via subcutaneous injections. Participants will attend study visits for safety assessments including monitoring adverse events, vital signs, ECGs, and laboratory tests from screening through up to 261 days. Pharmacokinetic and pharmacodynamic evaluations will measure drug levels and effects on glucose, lipids, body weight, and liver fat using tests such as continuous glucose monitoring, mixed meal tolerance tests, MRI, and MRS scans. The study also tracks antibody development to AZD9550 and monitors participant adherence and tolerability throughout the study duration.
CONDITIONS
Brief 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 for Parts A-D or up to 75 years for Parts E-F at screening.
- Participants with or without type 2 diabetes mellitus (T2DM) depending on study part.
- If with T2DM, must have glucose control managed with diet and stable medication doses as specified.
- HbA1c within target ranges: 6% to 10% for Parts A-E, less than 6.5% for Part F.
- Body mass index (BMI) from 27 to 39.9 kg/m2 for Parts A-C, BMI 27 or higher for Part E, or BMI 30 or higher for Part F.
- Use of contraception consistent with local regulations.
- Written informed consent obtained prior to study procedures.
- Ability to complete eligibility and randomisation within 60 days of consent.
- Suitable venous access for multiple blood draws.
- Willingness and ability to receive weekly subcutaneous injections for Parts C, D, E, and F.
You will not qualify if you...
- Use of insulin in participants with T2DM (Parts A-E) and T2DM participants in Part F.
- More than three anti-diabetic therapies in T2DM participants (Parts A-D).
- Treatment with GLP-1 receptor agonists within specified washout periods.
- Clinically important diseases that pose risk or affect study participation.
- Thyroid C-cell hyperplasia or medullary thyroid carcinoma history.
- Significant gastrointestinal, renal, hepatic disease (except Gilbert’s syndrome) affecting drug metabolism.
- Recent cancer history excluding non-melanoma skin cancer.
- Significant illness apart from T2DM.
- Recent surgery or trauma within 4 weeks.
- Symptoms of poor glucose control.
- Positive hepatitis B, C, or HIV infection.
- Abnormal liver enzymes or blood abnormalities beyond defined limits.
- Impaired renal function below defined thresholds.
- Abnormal vital signs or ECG findings affecting safety.
- Cardiac device presence or arrhythmias.
- Recent heart conditions or hospitalisations.
- History of drug abuse, severe allergies, psychiatric conditions, or recent use of certain medications.
- Recent participation in other drug studies.
- Ongoing weight loss diets or weight loss agents unless stopped 3 months prior with stable weight.
- Specific dietary restrictions, nicotine use, or inability to communicate reliably.
- Employment or close relation to study sponsor or site staff.
- Contraindications to MRI in applicable parts.
- High serum triglycerides or recent marijuana use as specified.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 weeks depending on cohort assignment
Participants receive multiple ascending doses of AZD9550 alone or combined with AZD6234, or placebo, through subcutaneous injections with dose frequency varying from weekly to bi-weekly or monthly over several parts of the study.
Weekly or bi-weekly/monthly visits depending on dosing schedule
Duration - Up to approximately 8 weeks post-treatment
Participants are monitored for safety, tolerability, and pharmacokinetics after the last dose of study medication.
Visits during 14 days post last dose and additional follow-up visits as scheduled
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
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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