Phase 3 is where the peptide pipeline actually monetizes. The trials that drive prescribing labels and payer coverage land here.
Recent and active Phase 3 programs covered on this site: SURMOUNT-5 (tirzepatide vs semaglutide), ACHIEVE-3 (orforglipron in obesity), TRIUMPH (retatrutide), REDEFINE-1 and -2 (CagriSema), SYNCHRONIZE-1 (Zealand's survodutide), REMODEL (semaglutide kidney), the SELECT cardiovascular outcomes trial, BriaCell's Bria-IMT in metastatic breast cancer, and AMPLIFY-201 (ELI-002 KRAS vaccine). Outside obesity and oncology, Boehringer Ingelheim, Crinetics, Verismo, and Lirum have active Phase 3 readouts in adjacent indications.
Stories here cover top-line readouts, full-data presentations at AACR, AAN, ESCMID, and AOSSM, and the FDA filings that follow.
Eli Lilly's retatrutide MASLD Phase 3 program (NCT06859268) continues enrollment across multiple international sites following the December 2025 Phase 2 readout that documented 86% mean liver-fat reduction at 48 weeks on 12 mg dosing. The Phase 3 trial enrolls adults with biopsy-confirmed MASH stages F2-F3 with primary endpoint at week 52 measuring MASH resolution without worsening of fibrosis. The 86% liver-fat reduction substantially exceeds the resmetirom 38-46% benchmark from the MAESTRO-NAFLD-1 reference cohort. Topline data is expected H1 2027; full results at AASLD or EASL 2027. The MASLD Phase 3 sits alongside TRIUMPH-3 (obesity + CVD) and TRIUMPH-OUTCOMES (10,000-patient cardiovascular outcomes trial reading 2027) as the second 2027 retatrutide catalyst. If positive, retatrutide files for MASH labeling alongside the obesity NDA — potentially within the same FDA submission window.
Eli Lilly announced TRIUMPH-1 topline results May 21 from the 80-week Phase 3 registrational trial of retatrutide — a first-in-class GIP/GLP-1/glucagon triple-receptor agonist — in 2,339 adults with obesity or overweight and at least one weight-related comorbidity, without diabetes. Mean body weight loss was 28.3% (70.3 lbs) at 12 mg, 25.9% at 9 mg, and 19.0% at 4 mg, all versus 2.2% on placebo. All three doses met the primary and key secondary endpoints. 45.3% of participants achieved ≥30% weight loss — bariatric-surgery territory. A 104-week extension in adults with baseline BMI ≥35 saw mean weight loss reach 30.3% (85.0 lbs) on 12 mg. Full data presentation is scheduled for ADA 2026 in New Orleans (June 5-8). Lilly's NDA filing follows the TRIUMPH-2 (obesity + T2D) and TRIUMPH-3 (obesity + established cardiovascular disease) readouts expected later in 2026.
Novo Nordisk's AMAZE-12 Phase 3 trial of amycretin — a dual GLP-1 and amylin receptor agonist — began recruiting on May 18, 2026. The trial evaluates amycretin specifically for weight maintenance after initial weight loss, distinguishing it from AMAZE-1 (which measures body weight change over 84 weeks). The amycretin clinical rationale rests on Phase 1 weekly subcutaneous dosing producing 22% weight reduction at 36 weeks and oral formulation producing 13.1% at 12 weeks — both reported in the Lancet earlier in 2026. Amycretin sits within Novo's next-generation pipeline alongside CagriSema (cagrilintide + semaglutide, FDA filing under review with decision expected late 2026) and the orexin-related pipeline acquired via Centessa. The amycretin program is structurally Novo's most direct response to Lilly's retatrutide.
BriaCell announced May 14 it has completed manufacturing of clinical supplies for Bria-PROS+, the company's prostate cancer cell-based immunotherapy candidate, positioning the program for an IND filing and Phase 1/2 initiation later in 2026. On May 13, BriaCell added Penn Medicine's Abramson Cancer Center as a clinical site for the pivotal Phase 3 Bria-IMT metastatic breast cancer study, bringing the trial-site network to include Smilow Cancer Hospital at Yale New Haven and Los Angeles Cancer Network. The two announcements come ahead of BriaCell's six accepted ASCO 2026 abstract presentations on Bria-IMT and Bria-OTS+ in metastatic breast cancer, scheduled for the May 29-June 2 Chicago meeting. The May 6 FDA clearance for the Bria-BRES+ clinical study completes a busy two-week operational cadence for the company.
Eli Lilly's TRIUMPH program for retatrutide — a triple GIP/GLP-1/glucagon receptor agonist — has TRIUMPH-1 (general obesity without T2D, 80 weeks, 2,007 participants) and TRIUMPH-2 (obesity + T2D) reading out in Q2-Q3 2026. Both are pivotal for the planned NDA filing. The earlier TRIUMPH-4 readout in December 2025 delivered 28.7% mean weight loss at 68 weeks on 12 mg dosing with 75% knee osteoarthritis pain reduction. The full TRIUMPH program runs eight pivotal trials with >5,800 participants total: obesity, T2D, OSA, MASLD, knee OA, cardiovascular outcomes (TRIUMPH-OUTCOMES, ~10,000 patients reading out 2027), and dose-extension studies. A new safety signal noted in Phase 2 — a small uptick in mild-to-moderate hepatic enzyme elevations on 12 mg dosing — will be monitored carefully in Phase 3 readouts. Lilly's $4.5B Lebanon Indiana investment (announced May 6) targets retatrutide manufacturing capacity ahead of the 2027 approval window.
Entera Bio reported Q1 2026 May 8 with $20.4M cash and an updated Phase 3 plan for EB613, an oral once-daily PTH(1-34) tablet that would be the first oral osteoanabolic for postmenopausal osteoporosis. The streamlined Phase 3 protocol — submitted to the FDA in March — covers 750 postmenopausal women with primary endpoint of total hip BMD change from baseline at month 12. Trial initiation is targeted for late 2026, with topline H2 2028 — roughly one year earlier than previously guided. The molecule applies Entera's N-Tab oral peptide platform to teriparatide, the active ingredient in Forteo. The Phase 2 dose-ranging study in 161 patients met primary (PD/bone-turnover biomarker) and secondary (BMD) endpoints.
Novo Nordisk confirmed in its Q1 2026 commentary that a higher-dose CagriSema (cagrilintide 2.4 mg + semaglutide 2.4 mg) Phase 3 trial will start in the second half of 2026, in response to the February 23 readout where the lower-dose 2.4/2.4 mg arm achieved 23% mean weight loss vs. 25.5% on tirzepatide 15 mg over 84 weeks — failing the non-inferiority primary endpoint. The original CagriSema FDA filing is already submitted with a decision expected in late 2026; the higher-dose program is meant to position Novo for a more competitive head-to-head against tirzepatide before the retatrutide TRIUMPH readouts arrive. ECO 2026 in Istanbul (May 12–15) will deliver additional CagriSema data alongside Wegovy 7.2 mg.
ResearchAndMarkets published an April 21 PDC market landscape report counting six peptide-drug conjugates currently in Phase III trials and approximately 96 in development across the global pipeline. Lutathera remains the only FDA-approved PDC after Pepaxto's withdrawal, though Pepaxto retains EMA and MHRA approval. The report flags 34% year-over-year growth in clinical-trial registrations for peptide-based oncology compounds, with the majority targeting solid tumors previously considered peptide-resistant. Phase 2 ADC peptide-linker data released in early 2026 shows tumor-specific payload delivery rates above 85% — nearly double the 2023 benchmark — driven by the proteolytic-stability work that lets linker peptides survive serum peptidase degradation long enough to reach solid tumors.
Eli Lilly's retatrutide MASLD Phase 3 trial (NCT06859268) is enrolling, building on Phase 2 data that reported up to 86% liver-fat reduction at 48 weeks with 93% of 12 mg patients reaching normal liver fat. The MASLD trial will measure histological resolution of steatohepatitis without worsening fibrosis — the endpoint that drives FDA approval in the indication. The trial sits within the broader TRIUMPH program of seven Phase 3 retatrutide readouts due in 2026, after TRIUMPH-4 (28.7% mean weight loss with knee-osteoarthritis pain reduction) and TRANSCEND T2D1 (A1c down 1.7–2.0 pts in T2D). MASLD remains a regulatory test for incretins after Boehringer's survodutide LIVERAGE Phase 3 program.
On the April 23 Q1 call and follow-up coverage, Roche clarified that its two Phase 3 enicepatide (CT-388) obesity trials — ENITH 1 and ENITH 2 — were both successfully initiated in Q1, with the dual GLP-1/GIP agonist on track to compete in the next-wave Phase 3 obesity readouts. Phase 2 reported 22.5% placebo-adjusted weight loss for enicepatide. Roche also confirmed the petrelintide+enicepatide fixed-dose combination Phase 2 will dose its first patient around mid-2026, pairing the Zealand-derived amylin analog (placebo-like tolerability, 10.7% mean weight loss in ZUPREME-1 at week 42) with Roche's stronger GLP-1/GIP backbone. Additional Phase 2 readouts for oral GLP-1 CT-996 are guided before year-end 2026.
On the April 30 Q1 2026 call, Eli Lilly disclosed positive topline results from TRANSCEND T2D1, the first Phase 3 trial of retatrutide (triple GLP-1/GIP/glucagon agonist) in adults with type 2 diabetes. Compared with placebo, retatrutide lowered A1c by an average of 1.7 to 2.0 percentage points across doses and produced mean weight loss of 11.1 to 16.6 kilograms (25 to 37 pounds). The data complement the previously reported TRIUMPH-4 obesity-with-knee-osteoarthritis results (28.7% weight loss, 75.8% pain reduction). TRIUMPH-1, an 80-week obesity study, is the next retatrutide readout expected, with seven additional Phase 3 readouts still to come in 2026 ahead of a planned regulatory submission late 2026 or 2027.
Following the April 28 SYNCHRONIZE-1 obesity topline (16.6% weight loss at 76 weeks), Boehringer Ingelheim and Zealand Pharma confirmed that survodutide — their dual GLP-1/glucagon agonist — has two global Phase 3 MASH trials underway: LIVERAGE in adults with MASH and fibrosis stages F2 or F3, and LIVERAGE-Cirrhosis in compensated MASH cirrhosis. The Phase 3 program follows Phase 2 data showing 83% of MASH patients achieved histological improvement at 48 weeks. The MASH track positions survodutide alongside tirzepatide's SYNERGY-NASH and broader Lilly Phase 3 activity in the metabolic-liver-disease space, with full SYNCHRONIZE-1 data slated for ADA 2026 in June.
Zealand Pharma announced April 29 that it and partner Roche have formally endorsed advancing petrelintide — a long-acting amylin analog suitable for once-weekly subcutaneous administration — into Phase 3 trials for chronic weight management, with initiation planned for H2 2026. The Phase 3 program will evaluate petrelintide as monotherapy and in combination with Roche's GLP-1/GIP receptor dual agonist enicepatide (CT-388). The decision follows positive Phase 2 ZUPREME-1 data showing up to 10.7% weight loss with placebo-like tolerability; petrelintide is now positioned as the lead non-GLP-1 obesity asset behind only Novo's CagriSema.
Boehringer Ingelheim and Zealand Pharma announced positive topline results from the Phase 3 SYNCHRONIZE-1 trial of survodutide (BI 456906), a glucagon/GLP-1 dual agonist, in adults with obesity or overweight without type 2 diabetes. Adults treated with survodutide achieved 16.6% mean weight loss at 76 weeks (efficacy estimand) versus 3.2% placebo (p<0.0001), with up to 85.1% of treated adults achieving ≥5% weight reduction. Up to 39.2 lb (17.8 kg) average weight loss; initial analysis indicates predominantly fat-tissue loss with lean mass contributing only a small proportion. Full data will be presented at ADA 2026 in June.
Boehringer Ingelheim confirmed completion of the 76-week primary endpoint visit for the last participant in Phase 3 SYNCHRONIZE-1. Topline data expected H1 2026 — making it one of the year's most anticipated obesity readouts. Survodutide is a glucagon/GLP-1 dual agonist co-developed with Zealand Pharma. The comprehensive SYNCHRONIZE program also includes SYNCHRONIZE-CVOT (cardiovascular outcomes, fully enrolled). All key trials are scheduled to read out at scientific meetings throughout 2026, potentially paving the way for regulatory submission as the third major obesity GLP-1-class drug after semaglutide and tirzepatide.
Novo Nordisk announced April 23 positive topline results from the PIONEER TEENS trial: a 52-week, randomized, double-blind, placebo-controlled Phase 3a study of oral semaglutide (3, 7, or 14 mg once daily) in 132 children and adolescents aged 10-17 with type 2 diabetes. Oral semaglutide reduced HbA1c by 0.83 percentage points more than placebo at 26 weeks with a well-tolerated safety profile. Pending regulatory approvals, it would be the first oral GLP-1 RA for this pediatric population. Novo expects to file for label expansion in the US and EU in H2 2026.
Ahead of Amgen's April 30 Q1 2026 earnings release, analyst coverage highlighted MariTide as the company's most closely-watched pipeline asset. The bispecific GLP-1 RA / GIPR antagonist delivered up to 20% weight loss at 52 weeks in Phase 2 and is now enrolled across six global Phase 3 trials — with monthly, bi-monthly, and potentially quarterly dosing as its primary commercial differentiator against weekly GLP-1s. Amgen recorded $35.1 billion in 2025 product sales (+10%), and MariTide headline data from the Phase 3 program is expected to begin reading out in 2027.
CLINUVEL presented afamelanotide (Scenesse) vitiligo data at the American Academy of Dermatology annual meeting to 20,000+ delegates. The Phase III CUV105 trial has completed enrollment of 200+ patients across 3 continents. Clinical cases showed repigmentation after 20 weeks maintained through 6-month follow-up, even in patients with active disease. Topline results expected H2 2026.