Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Glucagon-like peptide-1 (GLP-1) analogue
ROSE-010 · 2 trials · 2 indications
The amount of food (weight and energy content) consumed during lunch after administration of ROSE-010 at 2 dose levels compared to placebo.
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was giving by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. For this outcome measure, the scans for the "fasting volume" and 2 "postprandial volumes" were used. The 2 postprandial (PP) volumes were averaged. Change was calculated as (PP - Fasting = gastric accommodation).
Half time (t1/2) of gastric emptying (GE) of solids is the time for half of the ingested solids or liquids to leave the stomach. The scintigraphy for GE t1/2 was done on Visit 2 (Day 0 of the study), the first day of scintigraphy.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Saline solution |
| ROSE-010 99 mcg | EXPERIMENTAL | ROSE-010 solution, 99 mcg, 0.5 ml |
| ROSE-010 150 mcg | EXPERIMENTAL | ROSE-010 solution, 150 mcg, 0.5 ml |
| ROSE-010 30 mcg | EXPERIMENTAL | A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
| ROSE-010 100 mcg | EXPERIMENTAL | A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
| ROSE-010 300 mcg | EXPERIMENTAL | A glucagon-like peptide-1 (GLP-1) analogue. A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later. |
| Name | Type | Description |
|---|---|---|
| ROSE-010 99 mcg | DRUG | Sub-cutaneous injection of ROSE-010 solution |
| Placebo | DRUG | Sub-cutaneous injection of saline solution |
| ROSE-010 150 mcg | DRUG | Sub-cutaneous injection of ROSE-010 solution |
| ROSE-010 | DRUG | The study medication was used in 30 mcg, 100 mcg, and 300 mcg subcutaneous injections daily, depending upon study arm. |
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 cl...
ROSE-010 is being developed for irritable bowel syndrome with constipation, known as C-IBS, and for obesity and overweight. Soligenix is studying it in both gastrointestinal and metabolic settings, with completed clinical work in C-IBS patients and in overweight and obese subjects.
ROSE-010 is developed by Soligenix, Inc., which trades under the ticker SNGX. The company is the sponsor of the clinical programs evaluating ROSE-010 in constipation predominant irritable bowel syndrome and in overweight and obese subjects.
ROSE-010 is in Phase 1 development overall, and it is investigational rather than approved. One completed trial is listed as Phase 1 and another completed trial is listed as Phase 2, so the program has spanned early clinical testing in both C-IBS and overweight or obese subjects.
ROSE-010 has been studied in two completed trials. NCT01056107 evaluated its effects on gastrointestinal transit in constipation predominant irritable bowel syndrome patients, enrolling 52 women. NCT06621017 examined the effect of the GLP-1 analogue ROSE-010 on appetite in overweight and obese subjects, enrolling 40 participants in the United States.
ROSE-010 is a small molecule GLP-1 analogue, so it acts on the GLP-1 receptor pathway. Its trial in overweight and obese subjects was designed to assess the effect of this GLP-1 analogue on appetite, while its C-IBS trial examined effects on gastrointestinal transit.