A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist
New Drug AZD6234 Tested for Weight Loss in Type 2 Diabetes
Plain English Summary
Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist is a Phase 2 clinical trial sponsored by AstraZeneca studying Endocrinology, Diabetes, Type II, Obesity. This study tests a new drug called AZD6234 to see if it helps people with type 2 diabetes and overweight or obesity lose weight. It is for adults with type 2 diabetes who are already taking a GLP-1 medication and have a BMI of 27 or higher. Participants will receive weekly injections of either AZD6234 or a placebo (a dummy drug) for 26 weeks. Alternatives include lifestyle changes, other diabetes medications, and bariatric surgery. The trial aims to enroll 69 participants.
Official Summary
This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18-75 with type 2 diabetes for at least 180 days. Must have an HbA1c between 6.0% and 10% and a BMI of 27 or higher. Must be on a stable dose of an injectable GLP-1 medication. Cannot have used other weight loss medications recently, had significant weight changes, or have severe kidney problems. This trial is studying Endocrinology, Diabetes, Type II, Obesity, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure how much weight participants lose and if they achieve a 5% or greater reduction in body weight after 26 weeks, indicating the drug's effectiveness in weight management. The specific primary outcome measures are: Percent change in body weight from baseline at Study Week 26 (From baseline to week 26); Weight loss ≥ 5% from baseline at Study Week 26 (From baseline to week 26). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses the need for more effective weight management tools for individuals with type 2 diabetes who are already on GLP-1 therapy, a common treatment for the condition. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Endocrinology, Diabetes, Type II, Obesity, where improved treatment options are needed.
Investor Insight
This trial signals potential for a new treatment option in the large and growing market for diabetes and obesity management, with AZD6234 aiming to improve upon existing therapies. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if AZD6234 is suitable for you, especially if you are already on GLP-1 medication. Participation involves weekly injections and regular clinic visits for 26 weeks to monitor progress and safety. Be prepared for potential side effects and discuss any concerns with your healthcare team. The trial is being conducted at 18 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: SEQUENTIAL
- Masking: TRIPLE
- Enrollment: 69 participants
Interventions
- DRUG: AZD6234 — Weekly SC injections of AZD6234
- DRUG: Placebo to match — Weekly SC injections of matching placebo
Primary Outcomes
- Percent change in body weight from baseline at Study Week 26 (From baseline to week 26)
- Weight loss ≥ 5% from baseline at Study Week 26 (From baseline to week 26)
Secondary Outcomes
- Weight loss ≥ 10% from baseline at Study Week 26 (From baseline to week 26)
- Absolute change in body weight (kg) from baseline at Study Week 26 (From baseline to week 26)
- Change in HbA1c from baseline at Study Week 26. (From baseline to week 26)
- AZD6234 plasma concentrations (From baseline to week 26)
- Change in serum glucose from baseline at Study Week 26. (From baseline to week 26)
Full Eligibility Criteria
Inclusion Criteria: 1. Be 18 to 75 years old at the time of signing the informed consent. 2. Diagnosed with type 2 diabetes ≥ 180 days before screening. 3. HbA1c value at screening of ≥ 6.0% (42 mmol/mol) and ≤ 10% (86 mmol/mol). 4. On a stable maintenance dose of an injectable GLP-1 RA. 5. At Screening, have a BMI ≥ 27 kg/m2 Exclusion Criteria: 1. Has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a GLP-1 RA). 2. Self-reported weight change of \> 5 % in the 3 months prior to screening. 3. Diabetes mellitus that is not clearly type 2 diabetes. 4. Use of insulin therapy for T2DM 5. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) 6. Significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) 8\. Impaired renal function defined as eGFR ≤ 45 mL/minute/1.73m2 at screening
Trial Locations
- Research Site, Birmingham, Alabama, United States
- Research Site, Mobile, Alabama, United States
- Research Site, Doral, Florida, United States
- Research Site, Jacksonville, Florida, United States
- Research Site, Miami, Florida, United States
- Research Site, Miami, Florida, United States
- Research Site, Winter Park, Florida, United States
- Research Site, Canton, Georgia, United States
- Research Site, Fayetteville, Georgia, United States
- Research Site, Chicago, Illinois, United States
- ...and 8 more locations
Frequently Asked Questions
What is clinical trial NCT06851858?
NCT06851858 is a Phase 2 INTERVENTIONAL study titled "Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist." It is currently active, not recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 69 participants.
What conditions does NCT06851858 study?
This trial investigates treatments for Endocrinology, Diabetes, Type II, Obesity. The primary condition under study is Endocrinology.
What treatments are being tested in NCT06851858?
The interventions being studied include: AZD6234 (DRUG), Placebo to match (DRUG). Weekly SC injections of AZD6234
What does Phase 2 mean for NCT06851858?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06851858?
This trial is currently "Active, Not Recruiting." It started on 2025-03-12. The estimated completion date is 2026-05-27.
Who is sponsoring NCT06851858?
NCT06851858 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06851858?
The trial aims to enroll 69 participants. The trial status is active, not recruiting.
How is NCT06851858 designed?
This is a interventional study, uses randomized allocation, follows a sequential design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06851858?
The primary outcome measures are: Percent change in body weight from baseline at Study Week 26 (From baseline to week 26); Weight loss ≥ 5% from baseline at Study Week 26 (From baseline to week 26). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06851858 being conducted?
This trial is being conducted at 18 sites, including Birmingham, Alabama; Mobile, Alabama; Doral, Florida; Jacksonville, Florida and 14 more sites (United States).
Where can I find official information about NCT06851858?
The official record for NCT06851858 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06851858. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06851858 testing in simple terms?
This study tests a new drug called AZD6234 to see if it helps people with type 2 diabetes and overweight or obesity lose weight. It is for adults with type 2 diabetes who are already taking a GLP-1 medication and have a BMI of 27 or higher.
Why is this trial significant?
This trial addresses the need for more effective weight management tools for individuals with type 2 diabetes who are already on GLP-1 therapy, a common treatment for the condition.
What are the potential risks of participating in NCT06851858?
Common side effects may include nausea, vomiting, diarrhea, or injection site reactions. The drug may affect blood sugar levels, and kidney function will be monitored. There is a risk that the drug may not be effective for everyone. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06851858?
Ask your doctor if AZD6234 is suitable for you, especially if you are already on GLP-1 medication. Participation involves weekly injections and regular clinic visits for 26 weeks to monitor progress and safety. Be prepared for potential side effects and discuss any concerns with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06851858 signal from an investment perspective?
This trial signals potential for a new treatment option in the large and growing market for diabetes and obesity management, with AZD6234 aiming to improve upon existing therapies. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive weekly injections of either AZD6234 or a placebo (a dummy drug) for 26 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.