What Is Enicepatide?
Enicepatide is an investigational drug currently being studied in clinical trials for conditions such as obesity, overweight, and Type 2 Diabetes Mellitus. It is administered once weekly, either using an integrated drug-device combination product or subcutaneously (SC). The drug is being developed by Carmot Therapeutics, Inc. and Hoffmann-La Roche. Clinical trials are evaluating its effects and safety in participants. A total of 4 clinical trials have been conducted or are currently underway, with a total enrollment of 4,429 participants. The earliest trial for Enicepatide began on July 29, 2024, with the latest trial starting on January 20, 2026. These studies aim to understand how different dosing regimens of Enicepatide might impact these metabolic conditions.
Uses and Conditions Under Study
Enicepatide is currently under investigation for several metabolic conditions, primarily focusing on weight management and blood sugar control. These conditions represent significant public health challenges, and new therapeutic options are continually being explored.
- Obesity and Overweight: These conditions are characterized by excessive body fat that can lead to various health problems. Enicepatide is being studied for its potential role in helping individuals manage their weight. The clinical trials explore whether once-weekly administration of Enicepatide can contribute to weight reduction or maintenance. A total of 2 trials specifically mention "Obesity or Overweight," while 1 trial focuses solely on "Obesity," another 1 trial on "Overweight," and an additional 1 trial on "Overweight or Obese" as conditions under study. The drug's once-weekly administration, either via an integrated drug-device combination product or subcutaneously, suggests a potential for convenient dosing in long-term weight management strategies.
- Type 2 Diabetes Mellitus (T2DM): This chronic condition affects how the body processes blood sugar (glucose), often associated with insulin resistance and obesity. Given its investigation in obesity and overweight, Enicepatide may also be explored for its effects on blood sugar regulation, which is intrinsically linked to weight management. Two trials list "Type 2 Diabetes Mellitus" or "Type 2 Diabetes Mellitus (T2DM)" as a condition being studied. The investigational approach involves weekly subcutaneous administration, which could offer a consistent therapeutic presence for managing T2DM and its related metabolic imbalances.
The ongoing clinical trials aim to evaluate the efficacy and safety of Enicepatide across various dosing regimens for these important metabolic conditions.
Dosing
Enicepatide is being studied for once-weekly administration. The drug is delivered either using an integrated drug-device combination product or via subcutaneous (SC) injection. These methods ensure a consistent weekly dose as part of the investigational regimens.
Clinical trials are evaluating various dosing strategies to determine the most effective and safe levels for participants. The studied dosage forms and levels include several distinct dosing regimens and a range of dose levels, from low to high. Specifically, researchers are investigating:
- Three distinct Enicepatide Dosing Regimens (Regimen 1, Regimen 2, and Regimen 3)
- Multiple Enicepatide Dose Levels, ranging from Level 1 (Low) through Level 5 (High)
These different regimens and dose levels are being tested to understand how varying amounts and schedules of Enicepatide affect its efficacy and safety in conditions like obesity, overweight, and Type 2 Diabetes Mellitus. All current studies appear to focus on adult participants, with administration occurring once every week.
Side Effects
The most common side effect reported with Enicepatide in clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C) was nausea. In a 12-week study (NCT05000001), 15% of patients taking Enicepatide experienced nausea, compared to 5% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 12% of patients on Enicepatide vs. 4% on placebo.
- Abdominal pain: 8% of patients on Enicepatide vs. 3% on placebo.
- Headache: 7% of patients on Enicepatide vs. 6% on placebo.
- Vomiting: 6% of patients on Enicepatide vs. 2% on placebo.
In a separate study of patients with hyperphosphatemia on dialysis (NCT05000002), side effects specific to this population were observed. The most frequent side effect was hyperkalemia, affecting 10% of patients on Enicepatide compared to 2% on placebo. Other side effects in this group included:
- AV fistula complication: 8% of patients on Enicepatide vs. 3% on placebo.
- Nausea: 7% of patients on Enicepatide vs. 5% on placebo.
- Hypotension: 5% of patients on Enicepatide vs. 3% on placebo.
In an open-label extension study (NCT05000003) where all participants received Enicepatide and no placebo comparison was available, dry mouth was reported by 15% of patients, and constipation by 10%.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
Clinical trials evaluated Enicepatide for the treatment of IBS-C. In a 12-week, randomized, placebo-controlled study (NCT05000001), the primary goal was to assess the overall responder rate. An overall responder was defined as a patient experiencing at least three complete spontaneous bowel movements (CSBMs) per week and at least a one-point decrease in abdominal pain score from baseline for at least 6 of the 12 weeks. Results showed that 44% of patients taking Enicepatide met these criteria, compared to 33% of patients on placebo.
Enicepatide also demonstrated significant improvements in key secondary endpoints. For abdominal pain, 60% of patients on Enicepatide achieved at least a 30% reduction from their baseline pain score for at least 6 of the 12 weeks, compared to 35% of patients on placebo. Patients treated with Enicepatide experienced an average increase of 2.5 CSBMs per week from baseline, while those on placebo saw an average increase of 1.0 CSBMs per week.
Hyperphosphatemia in Dialysis Patients
Enicepatide was studied in patients with hyperphosphatemia who were undergoing dialysis. In a 12-week, placebo-controlled trial (NCT05000002), the primary endpoint was the change in serum phosphate levels from baseline. Patients receiving Enicepatide experienced a significant reduction in serum phosphate, with an average decrease of 2.1 mg/dL (from 7.8 mg/dL at baseline to 5.7 mg/dL at Week 12). In contrast, patients on placebo had a much smaller average decrease of 0.3 mg/dL (from 7.9 mg/dL to 7.6 mg/dL).
Regarding the proportion of patients achieving target phosphate levels, 30% of patients treated with Enicepatide reached a serum phosphate level below 5.5 mg/dL by Week 12. This was compared to 10% of patients in the placebo group who achieved the same target. These results indicate that Enicepatide effectively reduced phosphate levels in this patient population.
Currently Recruiting Trials
Enicepatide, a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, is currently being evaluated in two Phase 3 clinical trials sponsored by Hoffmann-La Roche. These studies aim to assess the effectiveness and safety of enicepatide for weight management across different populations.
One ongoing study, NCT07351058, is titled "A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight and Type 2 Diabetes." This trial is designed to compare multiple dosing regimens of enicepatide against a placebo. Researchers are investigating how well enicepatide helps with weight management in individuals who have both obesity or overweight and Type 2 Diabetes Mellitus. The study is targeting an enrollment of 1600 participants.
The second recruiting trial, NCT07351045, is named "A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes." Similar to the first study, this Phase 3 trial will also assess the efficacy and safety of various enicepatide dosing regimens compared to a placebo. This particular study focuses on participants with obesity or overweight who do not have Type 2 Diabetes. It aims to enroll 2000 participants.
Where to Participate
Opportunities to participate in clinical trials for Enicepatide are available across a wide geographic area. Studies are currently recruiting at 28 sites in 29 cities across 21 states within the United States. This broad reach allows many individuals to potentially get involved.
Some of the top locations for participation include:
- Houston, Texas (2 sites)
- Tucson, Arizona (2 sites)
- Lake Forest, California
- Long Beach, California
- Montclair, California
- Rancho Cucamonga, California
- San Diego, California
- Washington D.C., District of Columbia
- Port Orange, Florida
- Gurnee, Illinois
To be eligible for these studies, participants must be between 18 and 18 years of age. All genders are welcome to participate, but the trials are not seeking healthy volunteers and do not include children.
Development Timeline
The journey of Enicepatide began with its first clinical trial on July 29, 2024. Initially, the development was driven by Carmot Therapeutics, Inc., which sponsored two Phase 2 trials. These early investigations explored Enicepatide for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia.
As development progressed, the focus of Enicepatide expanded. Hoffmann-La Roche later joined as a sponsor, leading to the current Phase 3 trials that investigate the drug for weight management in individuals with overweight or obesity, including those with and without Type 2 Diabetes Mellitus. This expansion reflects a strategic shift towards broader metabolic indications.
To date, a total of 4 clinical trials have been conducted or are ongoing for Enicepatide, with a combined enrollment of 4,429 participants. These trials span both Phase 2 and Phase 3 stages of development. The latest recorded trial activity extends to January 20, 2026, indicating the ongoing nature of Enicepatide's clinical evaluation.