A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or With… (NCT06151964) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
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
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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females aged 18 through 65 years (Parts A-D) or 75 years (Part E-F) 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).
. Diagnosed with T2DM.
. Are treated with diet and exercise only, or any combination of OAD with stable doses in the 3 months prior to dosing.
. Participants prescribed a DPP IV inhibitor or a GLP-1RA-containing medicine, alone or in combination with other OADs, may be eligible to enter the study if they have not been treated with any of these drugs for at least 35 days or 5 drug half-lives (whichever is longer) prior to randomisation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and percentage of participants with any AE, SAEs, AEs leading to discontinuation of study intervention, AEs with outcome of death, and AEs leading to withdrawal from study.
Timeframe: Day - 35 to Day 261
2
Number and percentage of participants with clinically significant changes from baseline in Vital Sign Parameters.
Timeframe: Day - 35 to Day 261
3
Number and percentage of participants with clinically significant changes in ECG parameters.
Timeframe: Day - 35 to Day 261
4
Number and percentage of participants with clinically significant changes from baseline in Clinical Laboratory Parameters
Timeframe: Day - 35 to Day 261
5
Area Under Concentration-Time Curve of AZD9550 following repeat weekly SC doses
Timeframe: Day 1 to Day 65
6
Maximum observed concentration of AZD9550 following repeat weekly SC doses
. Participants with a screening HbA1c value within the target range of
. Body mass index from ≥ 27 to ≤ 39.9 kg/m2 (inclusive) (Part A-C) or ≥ 27 kg/m2 (Part E), or ≥ 30 kg/m2 (Part F).
. Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
. Participants with T2DM (Part F) and participants with T2DM treated with insulin (Parts A-E).
. Participants with T2DM treated with more than 3 anti-diabetic therapies (Parts A-D only).
. Treatment with GLP-1RA or GLP-1RA/GIPRA within 3 months of screening (Parts A to C only) or within 35 days of randomisation or five half-lives (whichever is shorter) of dosing (Parts E and F only).
. History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
. Serum calcitonin suggestive of thyroid C-cell hyperplasia (calcitonin level \> 50 ng/L), medullary thyroid carcinoma, or history or family history of multiple endocrine neoplasia at screening.
. History or presence of GI, renal, or hepatic disease (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs, as judged by the investigator.
. History of cancer within the last 10 years, with the exception of non-melanoma skin cancer.
. Any clinically important illness (apart from T2DM), as judged by the investigator.
Half life associated with terminal phase elimination rate constant of AZD9550 following repeat weekly SC doses
Timeframe: Day 1 to Day 65
8
Time to maximum observed concentration of AZD9550 following repeat weekly SC doses
Timeframe: Day 1 to Day 65
9
Apparent oral clearance of AZD9550 following repeat weekly SC doses
Timeframe: Day 1 to Day 65
10
Apparent volume of distribution of AZD9550 following repeat weekly SC doses
Timeframe: Day 1 to Day 65
11
Ratio for AUC of AZD9550 following repeat weekly SC doses
Timeframe: Day 1 to Day 65
12
Ratio for Cmax of AZD9550 following repeat weekly SC doses