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New treatment option for Obesity and Obesity-related Medical Conditions
Official title A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes
ClinicalTrials.gov ID: NCT06924320
What this study is testing
What is MET233 and MET097?
MET233 and MET097 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity and obesity-related medical conditions.
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
- This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.
- 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 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
- BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D...
- Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital...
- Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs)...
- Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled...
You likely can't join if
- Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with...
- Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.
- Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
- Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
- Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit.
- Diagnosis of Type 1 diabetes.
See the full eligibility criteria
- Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
- BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening...
- Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
- Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
- Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled hypertension, and/or dyslipidemia.
- Participants in Parts E and G must not have any clinically significant diseases except hypertension, dyslipidemia, and/or a clinical diagnosis of sleep apnea.
- Willing and able to comply with all scheduled study visits, procedures, and required assessments.
- Women of childbearing potential must be willing to comply with protocol-specified contraceptive requirements and must not plan to become pregnant during the study.
- Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with protocol-specified contraceptive requirements.
- Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.
- Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
- Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
- Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit.
- Diagnosis of Type 1 diabetes.
- For Part A, Part B, Part D, Part E and Part G: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \> 6.4% or fasting plasma glucose \>126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
- For Part A, Part B and Part D: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
- Use of prohibited prescription or non-prescription medications, supplements, or investigational products within protocol-defined washout periods.
- History or presence of clinically significant gastrointestinal, endocrine, respiratory, renal, hepatic, hematologic, neurologic, cardiovascular, psychiatric, immunologic, or other systemic diseases, except where...
- Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, pancreatitis, or pancreatic cancer.
- History of acute or chronic pancreatitis or pancreatic cancer.
- Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.
- History of bariatric or weight-loss surgery.
- Clinically significant psychiatric illness that may interfere with study participation or safety.
- Screening assessments indicative of moderate to severe depression.
- History of drug or alcohol abuse or dependence within the past 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Cypress, California, 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 to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cypress, California, United States. 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.