SYNT-101 / Syntis Bio - LARVOL DELTA

28-Day Study to Evaluate the Safety, Tolerability, PK, and PD of SYNT-101 in Adults with Obesity (OBESITY WEEK 2026) - No abstract available

Clinical • Genetic Disorders • Obesity

Single Ascending Dose Study to Evaluate the Safety, Tolerability, PK, and PD of SYNT-101 in Adults (OBESITY WEEK 2026) - No abstract available

Clinical • Genetic Disorders • Obesity • Pediatrics

A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Syntis Bio | Recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Jul 2026

Trial completion • Trial completion date • Genetic Disorders • Obesity

Syntis Bio…announced initial safety, tolerability, and pharmacodynamic data from the single ascending dose (SAD) arm of its ongoing Phase 1/1b SYNTIETY-1 clinical trial evaluating SYNT-101 (Businesswire) - "These data will be presented at the 4th Obesity & Weight Loss Drug Development Summit....SYNT-101 was well tolerated at all dose levels, with no discontinuations, no serious adverse events, and no related GI adverse events....Single-tablet dosing was associated with favorable shifts in post-prandial endogenous satiety-related hormones, including: a 58% increase in total GLP-1, a 125% increase in peptide YY, a 21% reduction in ghrelin, and a 100% increase in leptin....Enrollment in the...overweight or obese patient...cohort is now complete and Syntis Bio expects to announce data from this arm later this year."

Enrollment status • P1 data • Obesity

Syntis Bio Announces First Patient Dosed in Phase 1/1b Clinical Trial of SYNT-101 in Obesity and Key Leadership Additions (Businesswire) - "The Phase 1/1b trial is being conducted in Australia and is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of SYNT-101 in healthy volunteers and in overweight or obese patients. The 28-day multi-ascending dose arm of the trial will also evaluate changes in relevant metabolic markers associated with weight management."

Trial status • Obesity

A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Syntis Bio | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Syntis Bio

New P1 trial • Genetic Disorders • Obesity

SYNT-101: First-in-Human Evaluation of a Pharmacologic Therapeutic to Replicate Gastric Bypass (OBESITY WEEK 2025) - "SYNT-101 has demonstrated safety, tolerability, and efficacy in first-in-human studies. Unlike many existing treatments, it offers an oral alternative to injectable or systemic therapies, potentially providing a more convenient and well-tolerated option. These early results suggest that SYNT-101 may have potential in the evolving landscape of weight loss therapies."

Bariatric surgery • First-in-human • P1 data • Genetic Disorders • Obesity • LEP

Preclinical Evaluation of SYNT-101: Effects on Weight Loss and Body Composition in DIO Rodents (OBESITY WEEK 2025) - "SYNT-101 demonstrates promising effects on weight loss, glucose metabolism, and body composition in DIO rodent models. Most notably, the treatment shows consistent, weekly weight loss, significantly reduced adiposity, while effectively preserving lean muscle mass, a critical limitation to existing weight loss interventions. These findings highlight the therapeutic potential of SYNT-101 for managing obesity and related metabolic disorders."

Preclinical • Genetic Disorders • Metabolic Disorders • Obesity

SYNT-101: First-in-Human Evaluation of a Novel Pharmacologic Therapeutic to Replicate Gastric Bypass for Management of Obesity (ENDO 2025) - "SYNT-101 has demonstrated a strong profile of safety, tolerability, and efficacy in first-in-human studies, showing promise as a well-tolerated therapeutic option for effective weight loss solutions. Unlike many existing treatments, SYNT-101 offers a safe, tolerable, and effective oral alternative to current injectable and/or systemic therapies for weight management."

Bariatric surgery • P1 data • Genetic Disorders • Obesity • Pain • LEP

Preclinical Evaluation of SYNT-101: Effects on Glycemic Control, Weight Loss, and Body Composition in DIO Rodents (ENDO 2025) - "SYNT-101 demonstrates promising effects on weight loss, glucose metabolism, and body composition in DIO rodent models. Most notably, the treatment shows consistent, weekly weight loss, significantly reduced adiposity, while effectively preserving lean muscle mass, a critical limitation to existing weight loss interventions. These findings highlight the therapeutic potential of SYNT-101 for managing obesity and related metabolic disorders."

Preclinical • Genetic Disorders • Metabolic Disorders • Obesity

Syntis Bio Closes $38 Million Financing to Accelerate Oral Therapies for Obesity and Rare Diseases (Businesswire) - "Syntis Bio, Inc...announced today the close of a $33 million oversubscribed Series A financing...Syntis has also secured up to $5 million in non-dilutive funding from the National Institutes of Health (NIH) through two Fast-Track Small Business Innovation Research (SBIR) awards from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), supporting the advancement of its SYNT (SYNthetic Tissue-lining) platform....The funding also enables the advancement of lead program SYNT-101 through Phase 1 studies as a once-daily treatment for obesity, as well as initiation of Phase 1 studies for SYNT-202, a first-in-class oral enzyme therapy for homocystinuria, a rare pediatric amino acid disorder."

Financing • Obesity • Rare Diseases

New daily ‘gastric bypass pill’ leads to consistent weight loss - and no side effects: study (New York Post) - P1a | N=31 | NCT03643627 | Sponsor: Syntimmune, Inc. | "The makers of the experimental drug SYNT-101 claim it mimics the effects of gastric bypass surgery while preserving lean muscle mass better than GLP-1 drugs....In a new first-in-human study, seven women and two men between the ages of 24 and 53, who were not considered obese, took varying doses of SYNT-101 in liquid form. Imaging confirmed that the coating formed across the upper small intestine, and tissue samples showed that SYNT-101 was safely expelled within 24 hours. Further testing showed the participants had normal liver function and lower glucose absorption."

P1 data • Obesity

SYNT-101: First-in-Human Evaluation of a Novel Pharmacologic Therapeutic to Replicate Gastric Bypass for Management of Obesity (ECO 2025) - No abstract available

Bariatric surgery • Late-breaking abstract • P1 data • Genetic Disorders • Obesity

Preclinical Evaluation of SYNT-101: Effects on Glycemic Control, Weight Loss, and Body Composition in Obese Rodents (ECO 2025) - No abstract available

Late-breaking abstract • Preclinical • Obesity

Syntis Bio Releases New Data Supporting Potential of SYNT-101 as a Once-Daily Oral Treatment for Obesity at European Congress on Obesity and Weight Management (Businesswire) - "In preclinical rodent models, SYNT-101 produced consistent 1% weekly weight loss over the six-week study period while preserving 100% of lean muscle mass....Notably, lean muscle mass was fully preserved throughout the study, and no adverse events were observed....Syntis plans to submit an investigational new drug (IND) application to the U.S. FDA in H2 2025."

IND • Preclinical • Obesity

Syntis Bio Releases New Data Supporting Potential of SYNT-101 as a Once-Daily Oral Treatment for Obesity at European Congress on Obesity and Weight Management (Businesswire) - P=NA | N=9 | "In a first-in-human pilot study, an investigational formulation of SYNT-101 demonstrated strong evidence of nutrient redirection and resulting satiety hormone modulation. Importantly, SYNT-101 displayed strong safety and tolerability across both studies, with no adverse events reported....No treatment-related adverse events were reported, and all biopsy samples showed normal tissue histology. Glucose tolerance testing confirmed effective nutrient diversion, with no changes in safety biomarkers and complete clearance within 24 hours. Additionally, participants demonstrated favorable acute postprandial shifts in appetite-regulating hormones, including increased leptin and decreased ghrelin, consistent with enhanced satiety signaling and metabolic regulation."

Clinical data • Obesity