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

NCT06621017 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RP-24-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

GLP-1; ROSE-010; Obesity; Overweight; Appetite depressant; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Food Consumption

  The amount of food (weight and energy content) consumed during lunch after administration of ROSE-010 at 2 dose levels compared to placebo.

  30 minutes

Secondary Outcomes (9)

• Hunger

  6.5 hours Day 7

• Satiety

  6.5 hours Day 7

• Prospective Consumption

  6.5 hours Day 7

• Desire to Eat

  6.5 hours Day 7

• Palatability

  30 minutes Day 7

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Saline solution

Drug: Placebo

ROSE-010 99 mcg

EXPERIMENTAL

ROSE-010 solution, 99 mcg, 0.5 ml

Drug: ROSE-010 99 mcg

ROSE-010 150 mcg

EXPERIMENTAL

ROSE-010 solution, 150 mcg, 0.5 ml

Drug: ROSE-010 150 mcg

Interventions

ROSE-010 99 mcg DRUG

Sub-cutaneous injection of ROSE-010 solution

ROSE-010 99 mcg

Placebo DRUG

Sub-cutaneous injection of saline solution

Placebo

ROSE-010 150 mcg DRUG

Sub-cutaneous injection of ROSE-010 solution

ROSE-010 150 mcg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History or presence of chronic pancreatitis or presence of acute pancreatitis within 6 months before Screening.
• A history of Major Depressive Disorder within the last 2 years.
• Any lifetime history of a suicide attempt.
• 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.
• 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.
• 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).
• 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.
• 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.

Sponsors & Collaborators

• Rose Pharma Inc: lead

Study Sites (1)

Medpace Clinical Pharmacology

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Anorexia

Interventions

glucagon-like peptide (7-37), valyl(10)-

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Results Point of Contact

• Title: Enda Kenny PhD
• Organization: Rose Pharma Inc

ek@rosepharmainc.com

+353 87 997 0841

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: September 26, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)