Obesity; OverweightPhase 2NCT06621017
Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects
A Phase 2 study testing ROSE-010 99 mcg and ROSE-010 150 mcg in people with Obesity; Overweight, run by Rose Pharma Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity; Overweight
- What is being tested?
- ROSE-010 99 mcg and ROSE-010 150 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 27 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Known allergy to any ingredient of ROSE-010 or any history of severe allergic reaction (including drugs, food, insect bites, or environmental allergens).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Daily Administrations of the GLP-1 Analogue ROSE-010 on Appetite and Food Intake in Overweight and Obese Subjects
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.
Read the 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.
- Conditions
- Obesity; Overweight
- Being tested
- ROSE-010 99 mcg, Placebo, ROSE-010 150 mcg
- Keywords
- GLP-1, ROSE-010, Obesity, Overweight, Appetite depressant, Pharmacokinetics
- Medical subject headings
- Obesity, Overweight, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROSE-010 99 mcgDrug
Sub-cutaneous injection of ROSE-010 solution
PlaceboDrug
Sub-cutaneous injection of saline solution
ROSE-010 150 mcgDrug
Sub-cutaneous injection of ROSE-010 solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline solution Receives: Drug: Placebo |
| ROSE-010 99 mcg | Experimental | ROSE-010 solution, 99 mcg, 0.5 ml Receives: Drug: ROSE-010 99 mcg |
| ROSE-010 150 mcg | Experimental | ROSE-010 solution, 150 mcg, 0.5 ml Receives: Drug: ROSE-010 150 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (9)
Hunger
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.
Measured: 6.5 hours Day 7
Satiety
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.
Measured: 6.5 hours Day 7
Prospective Consumption
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.
Measured: 6.5 hours Day 7
Desire to Eat
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.
Measured: 6.5 hours Day 7
Palatability
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.
Measured: 30 minutes Day 7
Nausea
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.
Measured: 6.5 hours Day 7
Plasma PK Analysis of ROSE-010 Time to Max Concentration Tmax
Plasma PK analysis of ROSE-010: Time to max plasma concentration in minutes
Measured: Day 7
Plasma PK Analysis of ROSE-010 Cmax
Plasma PK analysis of ROSE-010, measurement of max plasma concentration.
Measured: Day 7
Half-life
Time of plasma elimination half-life calculated for both ROSE-010 doses
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Sep 2024
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity; OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rose Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621017
- Sponsor's protocol ID
- RP-24-02
- Status last verified
- Aug 2025
- First submitted
- 26 Sep 2024
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Daily Administrations of the GLP-1 Analogue ROSE-010 on Appetite and Food Intake in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT06621017
- Acronym / sponsor ID
- RP-24-02
- Conditions
- Obesity; Overweight
- Keywords
- GLP-1, ROSE-010, Obesity, Overweight, Appetite depressant, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rose Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline solution |
| ROSE-010 99 mcg | Experimental | Drug: ROSE-010 99 mcgROSE-010 solution, 99 mcg, 0.5 ml |
| ROSE-010 150 mcg | Experimental | Drug: ROSE-010 150 mcgROSE-010 solution, 150 mcg, 0.5 ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROSE-010 99 mcgSub-cutaneous injection of ROSE-010 solution | Drug | ROSE-010 99 mcg |
| PlaceboSub-cutaneous injection of saline solution | Drug | Placebo |
| ROSE-010 150 mcgSub-cutaneous injection of ROSE-010 solution | Drug | ROSE-010 150 mcg |
Primary outcome
Food Consumption
Time frame: 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.
9 secondary outcomes
Hunger
Time frame: 6.5 hours Day 7
Satiety
Time frame: 6.5 hours Day 7
Prospective Consumption
Time frame: 6.5 hours Day 7
Desire to Eat
Time frame: 6.5 hours Day 7
Palatability
Time frame: 30 minutes Day 7
Nausea
Time frame: 6.5 hours Day 7
Plasma PK Analysis of ROSE-010 Time to Max Concentration Tmax
Time frame: Day 7
Plasma PK Analysis of ROSE-010 Cmax
Time frame: Day 7
Half-life
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ROSE-010 99 mcg and ROSE-010 150 mcg in people with Obesity; Overweight, run by Rose Pharma Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Consumption (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.