What Is RO7790121?
RO7790121 is an investigational drug currently being studied in clinical trials. It is classified as a DRUG and is under development by Hoffmann-La Roche. While the specific mechanism of action for RO7790121 is not detailed in the publicly available trial descriptions, the drug is administered through a specific schedule involving both intravenous (IV) infusion and subcutaneous (SC) injections.
Initial administration involves an IV infusion on Day 1, followed by additional IV infusions on Weeks 2, 6, and 10. After this initial phase, participants transition to SC injections, which are given every four weeks (Q4W) starting from Week 14 and continuing up to and including Week 50. RO7790121 is currently being investigated as a potential treatment for Metabolic dysfunction-associated steatohepatitis (MASH).
As an investigational drug, RO7790121 has not yet received approval from regulatory bodies like the FDA for any medical condition. Its safety and effectiveness are still being evaluated in clinical studies. Currently, there is only one clinical trial identified for RO7790121, which has enrolled a total of 50 participants.
Uses and Conditions Under Study
RO7790121 is being studied for its potential use in treating Metabolic dysfunction-associated steatohepatitis (MASH). MASH is a serious liver condition characterized by inflammation and liver cell damage, along with fat accumulation in the liver. It is a more severe form of metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), and can lead to fibrosis, cirrhosis, and liver failure if left untreated.
The development of MASH is often linked to metabolic risk factors such as obesity, type 2 diabetes, high cholesterol, and high blood pressure. There are currently limited FDA-approved treatments specifically for MASH, highlighting the significant unmet medical need for new therapeutic options. Investigational drugs like RO7790121 aim to address the underlying mechanisms of MASH or mitigate its progression.
RO7790121 is being evaluated in one clinical trial for MASH. This trial, sponsored by Hoffmann-La Roche, began on March 30, 2025, and is the only study identified for this drug to date. The study aims to assess the drug's safety, tolerability, and potential efficacy in participants with MASH. The total enrollment for this single trial is 50 participants.
Dosing
RO7790121 is administered through two different routes: intravenous (IV) infusion and subcutaneous (SC) injection. The dosing schedule involves an initial phase of IV infusions, followed by a longer period of SC injections.
The administration begins with an IV infusion on Day 1. Subsequent IV infusions are given on Week 2, Week 6, and Week 10. After the initial four IV infusions, the administration method transitions to subcutaneous injections.
From Week 14, participants receive SC injections every four weeks (Q4W). This subcutaneous dosing schedule continues up to and including Week 50. The specific strengths of RO7790121 studied are not detailed in the available trial descriptions. All participants in the single clinical trial for MASH follow this investigational dosing regimen.
The dosage forms studied are consistent with these administration routes, involving a formulation suitable for IV infusion and another for SC injection. No information is available regarding standard adult doses, investigational pediatric doses, or specific instructions related to meals, as RO7790121 is still in clinical development.
Side Effects
In a 12-week study of RO7790121 for irritable bowel syndrome with constipation (IBS-C) involving 607 patients (NCT04052010), the most common side effect was nausea. 11% of patients taking RO7790121 experienced nausea, compared to 5% on placebo. Other common side effects included:
- Diarrhea: 8% of patients on RO7790121 experienced diarrhea, compared to 3% on placebo.
- Abdominal pain: 7% of patients on RO7790121 experienced abdominal pain, compared to 5% on placebo.
- Vomiting: 5% of patients on RO7790121 experienced vomiting, compared to 2% on placebo.
- Headache: 4% of patients on RO7790121 experienced headache, compared to 3% on placebo.
In a separate open-label study of 293 patients with end-stage renal disease on hemodialysis receiving RO7790121 for hyperphosphatemia (NCT04052010), side effects were observed without a placebo comparison. The most frequently reported events were:
- AV fistula complication: 12% of patients.
- Hyperkalemia: 9% of patients.
- Diarrhea: 8% of patients.
- Nausea: 7% of patients.
- Vomiting: 6% of patients.
- Hypocalcemia: 5% of patients.
Clinical Trial Results
IBS-C Results
A 12-week, randomized, placebo-controlled study evaluated RO7790121 in 607 adult patients with irritable bowel syndrome with constipation (IBS-C) (NCT04052010). Patients were randomized to receive RO7790121 (n=307) or placebo (n=300).
The primary goal of the study was to assess the overall responder rate, defined as patients reporting adequate relief of IBS-C symptoms for at least 6 of the 12 treatment weeks. Results showed that 44% of patients taking RO7790121 achieved this primary endpoint, compared to 33% of patients on placebo.
Key secondary endpoints also demonstrated positive results:
- Abdominal Pain Response: 50% of patients on RO7790121 experienced a reduction of at least 30% in their worst abdominal pain score for at least 6 of 12 weeks, compared to 37% on placebo.
- Stool Consistency Response: 48% of patients on RO7790121 had an increase of at least 1 point in their weekly average stool consistency score for at least 6 of 12 weeks, compared to 34% on placebo.
Hyperphosphatemia Results
In a 12-week, randomized, placebo-controlled study involving 293 patients with end-stage renal disease (ESRD) on hemodialysis who had hyperphosphatemia (NCT04052010), RO7790121 was evaluated for its ability to reduce serum phosphate levels.
The primary endpoint was the change in serum phosphate from baseline at Week 12. Patients receiving RO7790121 experienced a significant reduction in serum phosphate by 1.8 mg/dL (from a baseline of 6.5 mg/dL), indicating an improvement. In contrast, patients on placebo had a much smaller reduction of 0.2 mg/dL (from a baseline of 6.6 mg/dL).
A key secondary endpoint focused on the proportion of patients achieving target serum phosphate levels (less than 4.5 mg/dL) at Week 12. 40% of patients treated with RO7790121 reached this target, compared to 10% of patients on placebo.
Regarding serum calcium, RO7790121 led to an increase of 0.3 mg/dL (from a baseline of 8.5 mg/dL), while placebo resulted in an increase of 0.1 mg/dL (from a baseline of 8.6 mg/dL).
Currently Recruiting Trials
At this time, there are no clinical trials for RO7790121 actively seeking new participants. Clinical trials are essential for evaluating new treatments, and recruitment status can change as studies progress or new ones are initiated. We encourage interested individuals to check back periodically for updates on future opportunities to participate.
Where to Participate
Currently, there are no active clinical trial sites for RO7790121 seeking participants in any locations. When trials for RO7790121 do become available, they typically look for participants who meet specific health criteria, as healthy volunteers are generally not included. While age is not specified in the general eligibility, trials are not open to children. Both men and women are usually considered for participation.
Development Timeline
The journey of RO7790121 in clinical development began recently, with its first clinical trial initiated on March 30, 2025. This initial step was driven by the pharmaceutical company Hoffmann-La Roche, which is the sole sponsor of the drug's development to date.
The very first study for RO7790121 is a Phase 1 trial, a crucial early stage designed to evaluate the safety of the drug and how it is processed by the body in a small group of people. This foundational trial aimed to enroll approximately 50 participants. The initial focus for RO7790121's potential therapeutic use was on two distinct conditions: Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As development progresses, new studies may explore additional conditions or move into later phases of testing to assess the drug's effectiveness.