PG-102 / ProGen, SL Metagen - LARVOL DELTA

Rani Therapeutics Reports Second Quarter 2026 Financial Results; Provides Corporate Update (The Manila Times) - "Continues to advance RT-114 in the clinic with first participants dosed in the Phase 1a expansion cohort; additional data expected by end of 2026...Rani also announced today that the first participants have been dosed in the Phase 1a study expansion cohort of RT-114, an orally administered RaniPill Capsule delivering PG-102, a GLP-1/GLP-2 dual agonist being developed by ProGen Co., Ltd. The study was expanded to enroll fifteen additional healthy volunteers to provide a comprehensive pharmacokinetic dataset for the RaniPill HC as Rani moves toward initiating a Phase 1b repeat-dose study in patients with obesity by the end of 2026, with data anticipated in 2027."

New P1 trial • P1 data • Trial status • Obesity

Study Expansion and Next Steps (GlobeNewswire) - "Rani is expanding the Phase 1a study to include an additional cohort to further characterize the oral-to-subcutaneous pharmacokinetic relationship before advancing to the Phase 1b portion of the study. In this cohort, 15 healthy volunteers will each receive two separate 12 mg doses of PG-102 via the RaniPill (24 mg total administered dose). The data from this cohort are expected to inform dose selection for the planned Phase 1b portion of the study, which will assess the safety, tolerability and pharmacodynamic effect of eight weeks of repeat dosing with RT-114 in patients with obesity. The Phase 1b study is expected to begin in 2026, with data anticipated in 2027."

P1 data • Trial status • Obesity

Rani Therapeutics Announces Positive Initial Phase 1a Data for RT-114 for the Treatment of Obesity, with Oral Bioavailability Exceeding Matched Subcutaneous Dosing (GlobeNewswire) - "In the single-dose, open-label Phase 1a portion of the study, 30 healthy volunteers were randomized to receive an identical 12 mg dose of PG-102, delivered either orally via RT-114 or by subcutaneous injection....Treatment-related adverse events, including nausea, vomiting and diarrhea, were mild, transient and consistent with the known profile of GLP-1/GLP-2 dual agonists. Oral RT-114 achieved bioavailability greater than 150% relative to a matched subcutaneous dose of 12 mg PG-102. Elimination half-life was similar between arms: 5.6 days for oral RT-114 versus 5.3 days for subcutaneous PG-102."

P1 data • Obesity

Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: ProGen. Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Extended-Interval PG-102, a GLP-1/GLP-2 Bispecific Agonist, in Adults with Type 2 Diabetes (ADA 2026) - "This Phase 2a study evaluated the efficacy and safety of PG-102 administered biweekly or monthly in adults with type 2 diabetes (T2D). In this randomized, double-blind, placebo-controlled Phase 2a study, participants with T2D (HbA1c 7.0-10.0%, BMI 18.5-30 kg/m²) receiving stable metformin ± one oral antidiabetic drug were enrolled. PG-102 demonstrated significant HbA1c and fasting glucose reductions with both biweekly and monthly dosing. Favorable gastrointestinal tolerability and preferential fat mass reduction with lean mass preservation support further development of PG-102 as long-acting incretin therapy."

Bispecific • Clinical • Late-breaking abstract • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

ProGen pits GLP-1/GLP-2 drug against Ozempic in global phase 2b trial (Korea Biomedical Review) - "The trial will enroll 180 patients with type 2 diabetes across Korea and Australia. Participants will be randomized into three groups receiving either PG-102 at 60 mg once weekly, PG-102 at 90 mg once weekly, or semaglutide 1.0 mg over a 32-week treatment period....Through the phase 2b trial, ProGen plans to assess whether once-weekly dosing and escalation to 90 mg can improve metabolic efficacy while differentiating PG-102 from semaglutide in glycemic control and body composition effects."

New P2b trial • Type 2 Diabetes Mellitus

Bispecific GLP-1/GLP-2 agonism in advanced type 2 diabetes: preclinical characterization and a randomized, double-blind, placebo-controlled phase I trial. (PubMed, Nat Commun) - P1 | "PG-102 is a potency-optimized bispecific Fc fusion protein targeting GLP-1 and GLP-2 receptors...These findings support bispecific GLP-1/GLP-2 agonism as a mechanistically distinct incretin strategy in advanced T2D. ClinicalTrials.gov identifier: NCT06309667."

Clinical • Journal • P1 data • Preclinical • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: ProGen. Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Progen PG-102 draws attention as next-generation blockbuster at the European Association for the Study of Diabetes. [Google translation] (Hankyung) - "The first presentation addressed its efficacy in obese patients and animal models. In high-fat diet-induced obese mice, PG-102 dose-dependently reduced body weight while preserving muscle mass and selectively reducing visceral fat...The once-weekly PG-102 + bimagrumab combination group showed equivalent weight and fat loss to semaglutide, while demonstrating a clear advantage in muscle preservation. While the semaglutide + bimagrumab combination group recorded net muscle loss, the PG-102 + bimagrumab combination group achieved net muscle gain."

Preclinical • Obesity

Decoupling glycaemic control from weight loss in advanced type 2 diabetes using a bispecific GLP-1/GLP-2 agonist with enhanced human tolerability (EASD 2025) - P1 | "Comparisons were made against tirzepatide and retatrutide... PG-102 offers robust and sustained glucose lowering with preservation or recovery of body weight, even in metabolically vulnerable states. Unlike conventional GLP-1-based therapies that often link glycemic improvement with undesired weight loss, PG-102 demonstrates the potential to decouple these outcomes. This unique profile positions PG-102 as a next-generation incretin therapy for patients with advanced or lean T2D, where current options remain suboptimal."

Late-breaking abstract • Metastases • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

PG-102, a bispecific GLP-1/GLP-2 Fc fusion protein, outperforms dual-function peptide and combination therapy in preclinical models and induces dose-dependet weight loss in obese subjects (EASD 2025) - P1 | "PG-102, as a bispecific GLP-1/GLP-2 Fc-fusion protein, outperforms the dual peptide dapiglutide in delivering fat-selective, muscle-preserving weight loss in preclinical models. Its favorable tolerability and dose responsive efficacy in humans support its potential as a differentiated, next-generation obesity therapy. These findings support the continued clinical development of PG-102."

Combination therapy • Late-breaking abstract • Preclinical • Metabolic Disorders • Obesity

Weekly PG-102 plus bimagrumab enhances net muscle gain compared to daily semaglutide-based regimens (EASD 2025) - "PG-102 combined with Bimagrumab delivers a synergistic, next-generation obesity therapy that not only reduces fat mass effectively but also preserves—and even increases—lean muscle mass. Remarkably, this was achieved with once-weekly PG-102 dosing, unlike daily Semaglutide-based regimens. These results highlight the added clinical value of GLP-2 receptor engagement and suggest that PG-102 may enhance both muscle function and metabolic quality, supporting its potential to redefine obesity treatment."

Late-breaking abstract • Metabolic Disorders • Obesity • FBXO32

Phase II Study of PG-102(MG12) Compared With Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Active, not recruiting | Sponsor: ProGen. Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Mar 2025 ➔ Oct 2025

Enrollment closed • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Oral Delivery Of A Bispecific GLP-1/GLP-2 Receptor Agonist (PG-102) Via A Robotic Pill (RT-114) Achieves Bioequivalence To Subcutaneous Injection In Canines (ENDO 2025) - "Moreover, targeted intestinal delivery via RT-114 may better mimic physiologic incretin release, potentially enhancing gut-brain pathway engagement. Collectively, these compelling nonclinical results provide a robust rationale for initiating clinical development of RT-114 as a first in class oral anti-obesity therapy."

Late-breaking abstract • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants. (clinicaltrials.gov) - P1 | N=102 | Completed | Sponsor: ProGen. Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2026 ➔ Feb 2025 | Trial primary completion date: Feb 2026 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

ProGen lands $15.5 mil. from Yuhan, new backer JW to advance dual-target obesity drug (Korea Biomedical Review) - "ProGen has raised 22 billion won ($15.5 million) from a group of backers including Korea’s Yuhan Corp. and JW Pharmaceutical to speed up trials for its dual-agonist obesity drug and transition from Korea’s Konex to Kosdaq market later this year....The funding—comprised of convertible preferred shares and bonds—will support clinical trials and operations tied to PG-102, a dual GLP-1/GLP-2 receptor agonist currently in a phase 2 trial in Korea."

Financing • Obesity • Type 2 Diabetes Mellitus

Rani Therapeutics Announces Preclinical Data Demonstrating Bioequivalence of RT-114, a GLP-1/GLP-2 Dual Agonist (PG-102) Delivered Orally via the RaniPill Capsule, to Subcutaneously Administered PG-102 (GlobeNewswire) - "Rani Therapeutics Holdings...today announced pharmacokinetic and pharmacodynamic data from a preclinical study evaluating RT-114, a GLP-1/GLP-2 dual agonist (PG-102). PG-102 delivered orally via the RaniPill capsule demonstrated comparable bioavailability and weight loss to subcutaneously (SC) injected PG-102 ('SC PG-102'). PG-102 is ProGen Co., Ltd’s ('ProGen') Fc-fusion protein conjugated GLP-1/GLP-2 dual agonist."

Preclinical • Obesity

Progen, 'GLP-1/GLP-2' Obesity Phase 1 "Preliminary Efficacy Confirmed" [Google translation] (Biospectator) - P1 | N=34 | "ProGen announced on the 25th that it confirmed the weight loss effect and tolerability in the phase 1 repeated dose clinical trial (Part C) of the next-generation obesity and diabetes treatment candidate 'PG-102'...Efficacy evaluation results showed that patients in Cohort 2 showed an average weight loss of 4.8% and a maximum weight loss of 8.7% at week 5...Safety assessment results showed that nausea occurred in less than 30% of patients, diarrhea in less than 20% of patients, and no cases of vomiting were reported...ProGen plans to present the safety, tolerability, and weight loss results from the Phase 1 clinical trial of PG-102 through an oral presentation at the Asian Association for the Study of Diabetes (AASD 2025)....ProGen plans to submit an Investigational New Drug (IND) phase 1 clinical trial plan for 'RPG-102 (RT-114),' an oral obesity treatment drug being jointly developed with Rani Therapeutics in the United States, in the first half of this year."

IND • New P1 trial • P1 data • Diabetes • Obesity

Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Recruiting | Sponsor: ProGen. Co., Ltd. | Enrolling by invitation ➔ Recruiting

Enrollment status • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Phase II Study of PG-102(MG12) Compared with Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Enrolling by invitation | Sponsor: ProGen. Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants. (clinicaltrials.gov) - P1 | N=118 | Recruiting | Sponsor: ProGen. Co., Ltd. | N=90 ➔ 118 | Initiation date: Oct 2023 ➔ Mar 2024

Enrollment change • Trial initiation date • Genetic Disorders • Obesity

Phase II Study of PG-102(MG12) Compared With Placebo in Obesity and Type 2 Diabetes (clinicaltrials.gov) - P2 | N=144 | Not yet recruiting | Sponsor: ProGen. Co., Ltd.

New P2 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: ProGen. Co., Ltd. | Trial completion date: Jun 2024 ➔ Oct 2026 | Trial primary completion date: Jun 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date • Obesity

Progen, next-generation obesity and diabetes treatment 'PG-102' domestic phase 2 clinical trial plan approved [Google translation] (E-Today) - "Prozen announced on the 8th that it had received approval from the Ministry of Food and Drug Safety for the domestic phase 2 clinical trial plan (IND) for 'PG-102', which is being developed as a next-generation obesity and diabetes treatment drug. The phase 2 clinical trial will be conducted as a placebo-controlled and active-controlled trial to evaluate the safety and efficacy of PG-102 for patients with type 2 diabetes and obesity."

New P2 trial • Metabolic Disorders • Obesity

Progen, 'PG-102' nonclinical and early clinical results presented at the American Diabetes Association [Google translation] (The Bio) - "Progene announced on the 24th that it had presented the non-clinical and early clinical results of its next-generation dual-target obesity and diabetes treatment candidate, 'PG-102 (development code name),' in a poster session at the 84th American Diabetes Association (ADA) held at the Orlando Convention Center in the United States. In particular, the company explained that in a non-clinical animal model, it showed a superior blood sugar control effect than 'letatrutide'....According to Progene, PG-102...and showed superior glycemic control effects compared to competing substances in a mouse model of type 2 diabetes accompanied by obesity. While semaglutide, terzepatide, and retatrutide showed a maximum reduction of 1.8%, 2.5%, and 2.5% in glycated hemoglobin, respectively, PG-102 reached the normal range with a reduction of 5.2% without any hypoglycemic issues in a short period of time."

Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus