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Tests treatment safety and results for Adults With Overweight/Obesity and Type 2 Diabetes
Official title A Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide in Adult Participants With Type 2 Diabetes (T2D) and Overweight or Obesity
ClinicalTrials.gov ID: NCT07724340
What this study is testing
What is AT673 low dose?
AT673 low dose is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for adults with overweight/obesity and type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if AT673 contributes to additional weight loss and glycemic control when given with semaglutide in participants with overweight/obesity and type 2 diabetes. The main questions it aims to answer are: To compare the effect on body weight of two doses of AT673 once-weekly versus matched placebo when concurrently administered with semaglutide once-weekly To evaluate the effect of AT673 on glycated hemoglobin (HbA1c) To compare the safety and tolerability of AT673 versus matched placebo when concurrently administered with semaglutide
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent prior to start the Screening Visit procedures.
- Female and male participants ≥18 years of age at time of consent
- BMI g ≥27.0 kg/m2 at screening.
- HbA1c ≥7 and ≤10% (53-86 mmol/mol) at screening.
- Diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.
You likely can't join if
- Participant has had gastric bypass or other bariatric surgery or endoscopic procedure or any metabolic procedures (e.g. duodenal resurfacing...
- Liposuction and/or abdominoplasty that was performed \> 1 year before screening
- Laparoscopic gastric band that was removed \> 1 year before screening
- Intragastric balloon that was removed \> 1 year before screening
- Duodenal-jejunal bypass sleeve that was removed \> 1 year before screening.
- Participant has had a self-reported or medically recorded change in body weight \> 5% within 3 months of screening OR has recorded change in body...
See the full eligibility criteria
Who can join
- Signed informed consent prior to start the Screening Visit procedures.
- Female and male participants ≥18 years of age at time of consent
- BMI g ≥27.0 kg/m2 at screening.
- HbA1c ≥7 and ≤10% (53-86 mmol/mol) at screening.
- Diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.
- Either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, sulfonylurea, and/or DPP4 inhibitor as...
- Participant has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.
- Women of childbearing potential (WOCBP) meeting the criteria below: i) Non-lactating and has a negative pregnancy test at screening and baseline -AND- ii) Uses an acceptable method of contraception as determined by the...
- Participants must, in the opinion of the Investigator, be suitable candidates to receive semaglutide (Wegovy®) as indicated according to the product label.
What rules you out
- Participant has had gastric bypass or other bariatric surgery or endoscopic procedure or any metabolic procedures (e.g. duodenal resurfacing, intragastric balloon, etc.) except for the following:
- Liposuction and/or abdominoplasty that was performed \> 1 year before screening
- Laparoscopic gastric band that was removed \> 1 year before screening
- Intragastric balloon that was removed \> 1 year before screening
- Duodenal-jejunal bypass sleeve that was removed \> 1 year before screening.
- Participant has had a self-reported or medically recorded change in body weight \> 5% within 3 months of screening OR has recorded change in body weight \>3% between screening and randomization.
- Participant is currently using insulin or used insulin within 3 months before screening.
- Participant is currently using sulfonylureas and/or DPP4 inhibitors and is unable or unwilling to discontinue the use of these medications at least 24 hours prior to initiation of semaglutide.
- Participant has a form of diabetes other than type 2. a. Note: Previous diagnosis of gestational diabetes is permitted so long as the participant meets all inclusion and none of the exclusion criteria.
- Participant is currently using or used within 3 months before screening any weight reducing medication including pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion.
- Participant is currently using or used within 6 months before screening any medication that contains a GLP-1R agonist component or a GIPR modulator (either by prescription or as part of a clinical study)
- For participants with a history of prior GLP-1R agonist use (\> 6 months prior to screening):
- Participant has had a previous intolerance or hypersensitivity to GLP-1 receptor agonists or any of its excipients.
- Participant has previously discontinued a GLP-1 receptor agonist after continuous treatment for 6 months or longer due to not meeting personal weight loss goals.
- Participant is taking any medication that, may cause weight gain unless the participant has used these medications for more than 6 months at a stable dose prior to screening.
- Participant has hepatic liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase levels \>2.5, or total bilirubin levels \> 1.5 times the upper limit of normal (ULN) at...
- Participant's current alcohol intake exceeds 14 units/week for men or 7 units/week for women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits).
- Participant has a recent history of illicit substance use (\< 3 months) or in the opinion of the Investigator suspicion of current illicit substance use.
- Participant has uncontrolled hypertension at screening (SBP above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg).
- A corrected QT interval (QTc) of \> 450 msec in males or \> 470 msec in females at screening, or history of long QT syndrome.
- Concurrent participation in another treatment study (e.g., of a drug, over the counter product, device) or within ≤90 days or 5 half-lives prior to Screening.
- Participant is unable to understand and communicate with the investigators; or to understand the protocol requirements, instructions, study-related restrictions, nature, scope, and possible consequences of the clinical...
- Participant is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study, or employee of the sponsor...
- Participant whose obesity can be traced to a medical cause, suggestive of genetic or syndromic obesity of an endocrinologic disorder (e.g., hypothyroidism, Cushings syndrome, Prader-Willi syndrome).
- Participant has a history of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years, except for basal cell carcinoma.
- Participant has a glomerular filtration rate \< 60 mL/min/1.73 m2.
- Participant has a history of major psychiatric disorders within 5 years or lifetime history of suicide attempt.
- Participant has any suicidal ideation of type 4 or 5 on the C-SSRS at screening.
- Participant with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia (MEN) syndrome type 2.
- Participant with a previous history of chronic pancreatitis, or acute pancreatitis within 6 months prior to screening.
- In the opinion of the Investigator, any disorder, condition, inability or unwillingness not covered by the exclusion criteria that may interfere with study procedures, assessments or participant's safety.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Anaheim, California, United States
- Hollywood, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Savannah, Georgia, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Anaheim, California, United States; Hollywood, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Decatur, Georgia, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.