Enicepatide
Medium EvidenceAn investigational once-weekly, cAMP signal-biased dual GLP-1/GIP receptor agonist from Roche/Genentech that produced up to ~22.5% placebo-adjusted weight loss at 48 weeks in Phase 2 and is advancing to Phase 3 for obesity.
What It Is
Enicepatide (development codes CT-388 and RO7795068) is an investigational once-weekly subcutaneous dual GLP-1/GIP receptor agonist developed by Roche and its U.S. subsidiary Genentech for the treatment of obesity and overweight, including people with associated comorbidities such as type 2 diabetes. The molecule originated from Carmot Therapeutics, which Roche acquired in 2023, and is engineered as a cAMP signal-biased agonist: it activates both the GLP-1 and GIP receptors potently but with minimal to no beta-arrestin recruitment at either receptor. Because beta-arrestin drives receptor internalization and desensitization, this biased signaling is designed to limit receptor down-regulation and produce more prolonged pharmacological activity. In the Phase 2 CT388-103 dose-finding trial, which enrolled 469 adults living with obesity or overweight plus at least one weight-related comorbidity, enicepatide delivered a placebo-adjusted mean weight loss of 22.5% at 48 weeks (efficacy estimand) at the highest 24 mg dose, with no weight-loss plateau reached by week 48; the treatment-regimen estimand showed 18.3% placebo-adjusted weight loss (p<0.001). A clear dose-response was observed, and at 24 mg, 95.7% of participants achieved at least 5% weight loss, 87% at least 10%, 47.8% at least 20%, and 26.1% at least 30%. Among participants who were prediabetic at baseline, 73% returned to normal blood glucose by week 48 on the 24 mg dose. The therapy was generally well tolerated, with most gastrointestinal adverse events mild to moderate and a 5.9% discontinuation rate due to adverse events in the enicepatide arms versus 1.3% on placebo. Roche reported positive topline results in late January 2026 and is moving enicepatide into Phase 3 development. Late-breaking 48-week Phase 2 data (abstract 2813-LB, Lingvay I et al.) are being presented at the American Diabetes Association (ADA) 2026 Scientific Sessions (June 5-8, New Orleans). Roche also plans to initiate a Phase 2 multi-arm trial of enicepatide and petrelintide fixed-dose combinations around mid-2026, positioning enicepatide both as a standalone obesity medicine and as a backbone for combination therapy.
Regulatory Status
Positive Phase 2 (CT388-103) results reported January 2026; advancing to Phase 3. Not approved in any jurisdiction.
Effective: 2026
View FDA SourceWhy Researchers Study It
Enicepatide is closely watched because its Phase 2 weight-loss magnitude - up to roughly 22.5% placebo-adjusted at 48 weeks without a plateau - is among the largest reported for an incretin-based therapy, rivaling or exceeding established dual and triple agonists. Its cAMP signal-biased design is a novel pharmacological approach intended to reduce receptor desensitization and sustain activity, and researchers study it both as a potential best-in-class standalone obesity drug and as a backbone for fixed-dose combination with the amylin analog petrelintide. The Roche/Genentech program, built on the Carmot acquisition, also signals major commercial conviction in next-generation GLP-1/GIP biology.
Proposed Mechanisms
- Co-agonizes GLP-1 and GIP receptors to reduce appetite, improve satiety, and enhance glucose control
- cAMP signal-biased design activates receptors with minimal beta-arrestin recruitment
- Reduced receptor internalization and desensitization aims to prolong pharmacological activity
- Long-acting profile enables once-weekly subcutaneous dosing
- Positioned as a potential backbone for combination with the amylin analog petrelintide
Evidence Snapshot
| Study Type | Model | Outcome | Link |
|---|---|---|---|
| Human (Phase 2, CT388-103) | 469 adults with obesity or overweight plus >=1 weight-related comorbidity, 48 weeks | Up to 22.5% placebo-adjusted mean weight loss at 48 weeks (efficacy estimand) at 24 mg, no plateau; 18.3% by treatment-regimen estimand (p<0.001); at 24 mg, 87% achieved >=10% and 26.1% achieved >=30% weight loss | Source |
| Human (Phase 2, glycemic outcomes) | Prediabetic participants at baseline, 24 mg dose | 73% returned to normal blood glucose by week 48; discontinuation due to adverse events 5.9% (enicepatide) vs 1.3% (placebo), GI events mostly mild-to-moderate | Source |
| Development / regulatory | Roche/Genentech obesity program (originated at Carmot Therapeutics) | Positive Phase 2 topline reported Jan 2026; advancing to Phase 3; late-breaking 48-week data (2813-LB) at ADA 2026; Phase 2 enicepatide + petrelintide combination trial planned mid-2026 | Source |
Commonly Discussed Benefits
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Safety & Cautions
- Investigational; not approved in any jurisdiction
- Only Phase 2 efficacy and safety data reported to date; long-term outcomes unknown
- Full peer-reviewed CT388-103 publication not yet available
- Gastrointestinal adverse events and a higher AE-related discontinuation rate than placebo were observed
- Available only through clinical trial enrollment; not an FDA-approved or compounding-eligible peptide
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Citations
- [1] Roche to present new data advancing its obesity portfolio at the ADA 2026 Scientific Sessions (Jun 1, 2026) PubMed
- [2] Genentech Announces Positive Phase II Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People Living With Obesity (Jan 26, 2026) PubMed
- [3] Roche announces positive Phase II results for its dual GLP-1/GIP receptor agonist CT-388 in people living with obesity (Jan 27, 2026) PubMed
- [4] Adults with obesity lost up to 22.5% of weight at 48 weeks with novel drug (Healio, Jan 27, 2026) PubMed
- [5] Roche moves obesity drug to pivotal trials after mid-stage success (STAT, Jan 27, 2026) PubMed
- [6] A Study of CT-388 in Participants Who Are Overweight or Obese (Roche ForPatients) PubMed
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