Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects

Korábbi kezelés

• History or presence of chronic pancreatitis or presence of acute pancreatitis within 6 months before Screening.
• Previous bariatric surgery, procedure for obesity, or GI surgery altering GI passage, motility, and/or nutrient absorption or recent (within 6 months of Screening) changes in body weight (greater or equal to 5%) due to dieting, including commercial weight loss programs, or pharmacologic treatment.
• Currently on or planning to participate in any weight loss regimen during the course of the study.
• Use of any prescribed or over-the-counter (OTC) medication other than approved contraceptives within 14 days or 5 half-lives (whichever is longer) prior to dosing on Day 1 and throughout the study.
  • Note: Following study drug administration, medications used for the treatment of adverse events (AEs) may be allowed at the discretion of the Investigator or designee.

Más betegség

• Clinically significant or active gastric emptying abnormality (eg, gastroparesis or gastric outlet obstruction, intestinal obstruction, or any gastrointestinal [GI] motility disorders); malabsorption, including chronic constipation/diarrhea, celiac disease, inflammatory bowel disease, or bowel resection; or chronic use of drugs that directly affect GI motility (eg, anticholinergics, 5-hydroxytryptamine [serotonin] antagonists, opiates).
• Obesity induced by other endocrinologic disorders (eg, Cushing syndrome, acromegaly, inadequately treated hypothyroidism) or diagnosed monogenic or syndromic forms of obesity (eg, melanocortin 4 receptor deficiency or Prader-Willi syndrome).
• Thyroid disease that is not controlled (thyroid-stimulating hormone outside normal range at Screening).
• Symptomatic gallbladder disease within the past 2 years or history of cholecystectomy.
• A history of Major Depressive Disorder within the last 2 years.
• Any lifetime history of a suicide attempt.
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
• History of malignancy, except the following: curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colorectal polyps more than 5 years prior to Screening.
• Known allergy to any ingredient of ROSE-010 or any history of severe allergic reaction (including drugs, food, insect bites, or environmental allergens).

Laborértékek

• Abnormal fasting blood glucose (ie, greater than 125 mg/dL) at Screening or Check-In and/or HbA1c (greater than 6.4%) at Screening, or prior history/diagnosis of any type of diabetes mellitus (eg, type 1, type 2, or gestational).
• Any glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide dual agonist (eg, tirzepatide), or any prescription or OTC medications intended for weight loss or with a potential impact on weight and appetite regulation (eg, stimulant medications) within 6 months of Screening.

• Body mass index greater or equal to 27 and less than nor equal to 35 kg/m2 at Screening.
• Good health, as assessed by the Investigator, based on medical, surgical, and psychiatric history, physical examination, 12-lead electrocardiogram (ECG), vital sign assessments, and clinical laboratory evaluations at Screening and Check-In.
• Subjects must have a negative serum pregnancy test result at Screening and at Check-In and must not be pregnant, lactating, or planning a pregnancy from the Screening Visit to 30 days after the last dose of study drug.
• Female subjects of non-childbearing potential must be either surgically sterile (ie, had a hysterectomy, bilateral tubal ligation, bilateral salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to Screening) or postmenopausal (ie, have experienced spontaneous amenorrhea for at least 2 years, with a follicle-stimulating hormone level in the postmenopausal range at Screening based on the central laboratory's ranges).
• Subjects of childbearing potential (ie, ovulating, premenopausal, and not permanently surgically sterile) with male partners will be included if they are either sexually inactive (complete abstinence from heterosexual activity if in line with the subject's preferred and usual lifestyle) for at least 30 days prior to the first dose of study drug and agree to continue complete abstinence for at least 30 days after the last administration of study drug, or, if sexually active, agree to use a medically accepted contraceptive regimen during their participation in the study and for at least 30 days after the last administration of study drug.