Obesity; Overweight
Conditions
Keywords
GLP-1, ROSE-010, Obesity, Overweight, Appetite depressant, Pharmacokinetics
Brief summary
The primary objective of this study is to assess the efficacy of ROSE-010 on food intake in female subjects with overweight and obesity. The secondary objectives of this study are the following: * To assess the efficacy of ROSE-010 on hunger; * To assess the efficacy of ROSE-010 on satiety; * To assess the efficacy of ROSE-010 on prospective consumption; * To assess the efficacy of ROSE-010 on desire to eat; * To assess the efficacy of ROSE-010 on palatability; * To characterize the pharmacokinetics (PK) of ROSE-010 following subcutaneous (SC) administration on Day 1 and Day 7; and * To evaluate safety and tolerability of SC administrations of ROSE-010 to overweight and obese subjects.
Detailed description
This is a randomized, placebo-controlled, double-blind, parallel-group Phase 2 study evaluating the efficacy, safety, and PK of daily administrations of the GLP-1 analogue ROSE-010 on appetite and food intake in overweight and obese female subjects. The study is planned to include 3 parallel groups, as follows: Group 1: 99 mcg ROSE-010 (15 subjects) administered SC once daily for 7 consecutive days. Group 2: 150 mcg ROSE-010 (15 subjects) administered SC once daily for 7 consecutive days. Group 3: Placebo (10 subjects) administered SC once daily for 7 consecutive days. On Day 1, subjects will be randomized to receive ROSE-010 or placebo. Study drug will be administered SC once daily (30 minutes before lunch) for 7 consecutive days (Days 1 to 7). Assessments of hunger, satiety, prospective consumption, desire to eat, palatability, and nausea will be performed. Blood samples will be collected to evaluate PK.
Interventions
DRUGROSE-010 99 mcg
Sub-cutaneous injection of ROSE-010 solution
DRUGPlacebo
Sub-cutaneous injection of saline solution
DRUGROSE-010 150 mcg
Sub-cutaneous injection of ROSE-010 solution
Sponsors
Rose Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Body mass index greater or equal to 27 and less than nor equal to 35 kg/m2 at Screening. 2. 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. 3. 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. 4. 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). 5. 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.
Exclusion criteria
1. 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). 2. 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). 3. Thyroid disease that is not controlled (thyroid-stimulating hormone outside normal range at Screening). 4. Symptomatic gallbladder disease within the past 2 years or history of cholecystectomy. 5. History or presence of chronic pancreatitis or presence of acute pancreatitis within 6 months before Screening. 6. A history of Major Depressive Disorder within the last 2 years. 7. Any lifetime history of a suicide attempt. 8. 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. 9. Currently on or planning to participate in any weight loss regimen during the course of the study. 10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 11. 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. 12. 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). 13. 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. 14. 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. 15. Known allergy to any ingredient of ROSE-010 or any history of severe allergic reaction (including drugs, food, insect bites, or environmental allergens).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Consumption | 30 minutes | The amount of food (weight and energy content) consumed during lunch after administration of ROSE-010 at 2 dose levels compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hunger | 6.5 hours Day 7 | Hunger across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is not hungry at all and 100 is maximum hunger. AUE is a sum of hunger across the time period and is calculated as h\*mm. Simplistically, if the subject was not hungry at all across the period the AUE would be zero. The higher the AUE number, the higher the level of hunger throughout the observation period. |
| Satiety | 6.5 hours Day 7 | Satiety across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is not feeling full at at all and 100 is maximum feeling of fullness. AUE is a sum of satiety across the time period and is calculated as h\*mm. Simplistically, if the subject was not full at all across the period the AUE would be zero. The higher the AUE number, the higher the level of satiety throughout the observation period. |
| Prospective Consumption | 6.5 hours Day 7 | Prospective consumption across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is indicates no anticipated need to eat and 100 is maximum anticipated need to eat. AUE is a sum of prospective consumption across the time period and is calculated as h\*mm. Simplistically, if the subject has no anticipated need or desire to eat at all across the period the AUE would be zero. The higher the AUE number, the higher the level of prospective consumption throughout the observation period. |
| Desire to Eat | 6.5 hours Day 7 | Desire to eat across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is no desire to eat at all and 100 is maximum desire to eat. AUE is a sum of the desire to eat across the time period and is calculated as h\*mm. Simplistically, if the subject had no desire to eat at all across the period the AUE would be zero. The higher the AUE number, the higher the desire to eat throughout the observation period. |
| Palatability | 30 minutes Day 7 | Palatability (tastiness) score on a visual analogue scale (0 to 100 mm) where 0 is not palatable at all and 100 is the maximum palatibility. The higher the score, the more palatable the reported outcome. |
| Nausea | 6.5 hours Day 7 | Nausea across 6.5 hours of Area Under Evaluation (AUE) defined by time in hours (h) multiplied by the subject reported value on a visual analogue scale at each time point measured in mm on a 0 to 100 mm scale and where 0 is not nauseous at all and 100 is maximum nausea. AUE is a sum of hunger across the time period and is calculated as h\*mm. Simplistically, if the subject was not nauseous at all across the period, the AUE would be zero. The higher the AUE number, the higher the level of nausea throughout the observation period. |
| Plasma PK Analysis of ROSE-010 Time to Max Concentration Tmax | Day 7 | Plasma PK analysis of ROSE-010: Time to max plasma concentration in minutes |
| Plasma PK Analysis of ROSE-010 Cmax | Day 7 | Plasma PK analysis of ROSE-010, measurement of max plasma concentration. |
| Half-life | Day 7 | Time of plasma elimination half-life calculated for both ROSE-010 doses |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex/Gender, Customized Female | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 3 / 10 | 12 / 15 | 9 / 15 |
| serious Total, serious adverse events | 0 / 10 | 0 / 15 | 0 / 15 |
Outcome results
None listed