RecruitingPhase 1 / Phase 2

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

A PHASE 1/2A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MET233 CO-ADMINISTERED WITH MET097 IN ADULT PARTICIPANTS WITH OBESITY OR OVERWEIGHT INCLUDING PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well MET233 and MET097 work together to treat obesity or overweight. It is for adults ages 18 to 75, with or without diabetes, depending on the study part.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 75 years old.
  • Meet the body mass index (BMI) range for your study part. BMI is a measure of weight compared with height: 27–38 for Parts A, B, and C; 30–45 for Parts D and E; and 27–45 for Part G.
  • Have stable health based on your health history, exam, blood tests, and ECG, a test of the heart’s electrical activity.
  • Have no major health problems or test findings, except those allowed for your study part.
  • Part C allows type 2 diabetes, sleep apnea (breathing that stops and starts during sleep), well-controlled high blood pressure, and abnormal blood fats, such as cholesterol. Parts E and G allow high blood pressure, abnormal blood fats, and diagnosed sleep apnea.
  • Be willing and able to attend all study visits and complete all study tests and procedures.
  • If you can become pregnant, follow the study’s birth control rules and do not plan to become pregnant during the study.

Who can't join

  • Be pregnant or breastfeeding, or unable or unwilling to follow the study’s birth control rules.
  • Have blood pressure above 160/100, a resting pulse above 100 beats per minute, kidney filtering function (eGFR) below 80 mL/min, or lab results that could make the study unsafe or affect participation.
  • Have type 1 diabetes. For Parts A, B, D, E, and G: have type 2 diabetes, HbA1c (a measure of average blood sugar) above 6.4%, fasting blood sugar above 126 mg/dL, or any past use of blood sugar-lowering medicine.
  • Have a serious illness not specifically allowed by the study. For Parts A, B, and D, this also includes reported weight-related health problems, such as sleep apnea or heart and blood vessel disease.
  • Have a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia syndrome (a condition that causes tumors in hormone-making glands), pancreatitis (swelling of the pancreas), or pancreatic cancer.
  • Have joined a weight-loss program, with or without medicine, in the 3 months before study treatment, plan to join one, or have had weight-loss surgery.
  • Have used medicines, supplements, or other research treatments that are not allowed within the study’s required waiting periods, or have had drug or alcohol abuse or dependence in the past 2 years.
  • Have a serious mental health condition that could affect safety or participation, or screening results showing moderate to severe depression.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 for Parts G. * 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. Exclusion Criteria: * 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 explicitly permitted by the protocol. * 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.

Study sites (1)

CA