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    Cholesterol and fasting research tracker 2026

    2026 has been a busy year for cholesterol medicine. A new US guideline brought back LDL goals and universal Lp(a) testing, the FDA approved the first oral PCSK9 inhibitor (Lipfendra), and the EU approved obicetrapib.[1][2][3] The first Lp(a) outcome trial, of pelacarsen, missed its goal in September. On fasting, a Cochrane review found intermittent fasting no better than standard dietary advice for weight loss.[4][5]

    Editor reviewedStrict sourcingUpdated DevelopingHealth and medicine, GLP-1 and metabolic medicine, Life sciences

    What we know

    • The 2026 ACC/AHA guideline sets LDL goals of below 100, 70 or 55 mg/dL by risk level and recommends a one-time Lp(a) test for all adults.[7]
    • Enlicitide (Lipfendra) became the first FDA-approved oral PCSK9 inhibitor in July 2026.[2]
    • It is not yet known whether Lipfendra reduces cardiovascular events; its outcome trial runs to 2029.[10]
    • The European Commission approved obicetrapib (Ubeslo, Evlarco) on 21 September 2026, its first approval worldwide.[3]
    • Pelacarsen lowered Lp(a) but did not reduce cardiovascular events in Lp(a)HORIZON.[4]
    • Evolocumab reduced first cardiovascular events in people without a prior heart attack or stroke (VESALIUS-CV).[19]
    • A 2026 Cochrane review found intermittent fasting may make little to no difference to weight loss versus regular dietary advice.[5]
    • The peer-reviewed 8-hour eating study found an association with cardiovascular death but said residual confounding could not be ruled out.[18]

    What we don't know yet

    • Whether the PREVAIL interim analysis, planned for the fourth quarter of 2026, will show that obicetrapib reduces cardiovascular events.
    • What the full Lp(a)HORIZON data show when presented, and what they mean for olpasiran and lepodisiran.
    • When ORION-4 and VICTORION-2P will report whether inclisiran reduces cardiovascular events.
    • Whether obicetrapib will be filed for or approved in the United States.
    • Whether US guideline writers will adopt a single LDL goal below 55 mg/dL for all patients with atherosclerotic disease, as the chairs suggested after VESALIUS-CV.
    • Whether longer intermittent fasting trials, beyond 12 months, will change the picture on weight and cholesterol.
    Story status

    Story status

    State
    developing
    Started
    2021-12-22
    Timeline entries
    19
    Last entry

    Timeline data (JSON)

    This tracker follows research and regulatory news on cholesterol, lipid drugs and intermittent fasting, with background from 2021, when the FDA approved inclisiran.[6] It is updated as events happen; the timeline is newest first. Background is in the cholesterol explainer and intermittent fasting explainer.

    This page is general information, not medical advice. Talk to a clinician before acting on any study or approval.

    Guidelines

    The ACC, AHA and nine other organisations published a new US dyslipidemia guideline on 13 March 2026, replacing the 2018 guideline.[1] It restores LDL goals and recommends that every adult have Lp(a) measured once.[7][8] Its chair and vice-chair have already suggested that VESALIUS-CV should push future updates toward a single LDL goal below 55 mg/dL for everyone with atherosclerotic disease.[9]

    New drugs and approvals

    • Oral PCSK9. The FDA approved Merck’s enlicitide (Lipfendra) in July 2026, the first oral PCSK9 inhibitor.[2] Its outcome trial, CORALreef Outcomes, has an estimated primary completion date of November 2029.[10] See pcsk9-inhibitors.
    • CETP inhibition. The European Commission approved obicetrapib on 21 September 2026. NewAmsterdam planned a PREVAIL interim analysis for the fourth quarter of 2026, with results expected in early 2027.[3][11]
    • Triglycerides. The FDA approved olezarsen (Tryngolza) for severe hypertriglyceridemia on 24 June 2026.[12]
    • Inclisiran outcomes. ORION-4 had an estimated primary completion date of October 2026, and VICTORION-2P of May 2027.[13]

    Lp(a)

    Novartis said on 4 September 2026 that pelacarsen lowered Lp(a) but did not reduce cardiovascular events in the 8,323-patient Lp(a)HORIZON trial.[4] Olpasiran and lepodisiran outcome trials have estimated primary completion dates in 2028 and 2029.[14] See the Lp(a) explainer.

    Gene editing

    Gene-editing approaches continue to report data; see the gene editing tracker. CRISPR Therapeutics reported one-year CTX310 data in August 2026, with LDL down 53% at the highest dose.[15] Phase 1b results in severe hypertriglyceridemia are scheduled for the AHA meeting on 9 November 2026.[16]

    Fasting research

    The February 2026 Cochrane review found intermittent fasting may make little to no difference to weight loss compared with regular dietary advice.[5] A 2026 Nature Medicine trial in women with polycystic ovary syndrome found a 6-hour eating window matched daily calorie restriction.[17] The 2024 observational signal linking short eating windows to cardiovascular death remains unconfirmed by trials; see the evidence analysis.[18] For GLP-1 weight-loss drugs, see the metabolic medicine tracker.

    Timeline

    19 confirmed

    1. confirmed

      CTX310 severe-hypertriglyceridemia data set for AHA late-breaker on 9 November[16]

    2. confirmed

      Obicetrapib enters a Phase 2b Alzheimer's prevention trial[29]

    3. confirmed

      European Commission approves obicetrapib as Ubeslo and Evlarco[3]

    4. confirmed

      Pelacarsen misses primary endpoint in Lp(a)HORIZON outcome trial[4]

    5. confirmed

      One-year data for gene-editing therapy CTX310 show sustained LDL and triglyceride cuts[15]

    6. confirmed

      EMA committee recommends approval of obicetrapib in the EU[28]

    7. confirmed

      FDA approves enlicitide (Lipfendra), the first oral PCSK9 inhibitor[2][27]

      Merck announced the approval on 16 July; the FDA record shows a 15 July action date.

    8. confirmed

      FDA approves olezarsen (Tryngolza) to cut triglycerides and pancreatitis risk in severe hypertriglyceridemia[12]

    9. confirmed

      NewAmsterdam plans PREVAIL interim analysis for late 2026[11]

    10. confirmed

      Trial finds time-restricted eating matches calorie restriction in women with PCOS[17]

    11. confirmed

      New ACC/AHA dyslipidemia guideline restores LDL goals and recommends Lp(a) testing for all adults[1][7][8]

    12. confirmed

      Cochrane review finds intermittent fasting no better than regular dietary advice for weight loss[5][26]

    13. confirmed

      CORALreef Lipids results for oral enlicitide published in NEJM[25]

    14. confirmed

      VESALIUS-CV shows evolocumab prevents first heart attacks and strokes[19]

    15. confirmed

      Peer-reviewed 8-hour eating study published with hazard ratio of 2.35 and confounding caveat[18]

    16. confirmed

      BROADWAY trial of obicetrapib published, showing about a one-third LDL cut[24]

    17. confirmed

      BMJ network meta-analysis finds fasting diets broadly similar to calorie restriction[23]

    18. confirmed

      Conference abstract links eating windows under 8 hours to higher cardiovascular death[21][22]

      Observational NHANES analysis of about 20,000 adults; the AHA called it preliminary.

    19. confirmed

      FDA approves inclisiran (Leqvio), a twice-yearly PCSK9-blocking injection[6][20]

    Developing in Health

    Questions readers ask

    What were the biggest cholesterol developments of 2026?

    A new US dyslipidemia guideline in March, FDA approval of the first oral PCSK9 inhibitor (Lipfendra) in July, EU approval of obicetrapib in September, and the failure of pelacarsen, the first Lp(a)-lowering drug to complete an outcome trial, in September.[1][2][3][4]

    What is coming next?

    NewAmsterdam planned a PREVAIL interim analysis for the fourth quarter of 2026, CTX310 data are due at the AHA meeting on 9 November 2026, and inclisiran's ORION-4 trial had an estimated primary completion of October 2026.[11][16][13]

    What did 2026 research say about intermittent fasting?

    A February 2026 Cochrane review found little to no difference in weight loss versus regular dietary advice, while a small 2026 trial found a 6-hour eating window matched calorie restriction in women with PCOS.[5][17]

    Sources

    · 29 claims from 17 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      On 13 March 2026 the ACC, AHA and nine other organisations published a new US Guideline on the Management of Dyslipidemia in JACC, covering high blood cholesterol, hypertriglyceridemia and elevated Lp(a); it retires and replaces the 2018 cholesterol guideline. confirmedas of 2026-10-11

    2. [2]

      The FDA approved Merck's enlicitide (Lipfendra) 20 mg tablets in July 2026 (FDA action date 15 July; Merck announced it on 16 July) to lower LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, making it the first FDA-approved oral PCSK9 inhibitor. confirmedas of 2026-10-11

    3. [3]

      On 21 September 2026 NewAmsterdam and Menarini announced that the European Commission had granted marketing authorisation for Ubeslo and Evlarco, the first regulatory approval of obicetrapib worldwide, with a requirement to submit final results of the PREVAIL outcomes trial. confirmedas of 2026-10-11

    4. [4]

      On 4 September 2026 Novartis announced that its Phase III Lp(a)HORIZON trial of pelacarsen (8,323 patients with elevated Lp(a) and established cardiovascular disease) did not meet its primary endpoint of reducing cardiovascular events versus placebo, even though Lp(a) levels were lowered; full data are to be presented at a medical congress. Ionis described it as the first pivotal Phase 3 trial to test whether lowering Lp(a) reduces cardiovascular risk. confirmedas of 2026-10-11

    5. [5]

      A February 2026 Cochrane review of 22 randomised trials (1,995 adults with overweight or obesity, follow-up up to 12 months) covering time-restricted feeding, periodic fasting and alternate-day fasting, found intermittent fasting may result in little to no difference in weight loss compared with regular dietary advice (low-certainty evidence). confirmedas of 2026-10-11

    6. [6]

      The FDA approved Novartis's inclisiran (Leqvio, NDA 214012) as a new molecular entity on 22 December 2021. confirmedas of 2026-10-11

    7. [7]

      The 2026 ACC/AHA guideline brings back LDL cholesterol treatment goals of below 100 mg/dL for people at borderline or intermediate risk, below 70 mg/dL at high risk, and below 55 mg/dL for secondary prevention in people with ASCVD at very high risk. confirmedas of 2026-10-11

    8. [8]

      The 2026 ACC/AHA guideline recommends measuring Lp(a) at least once in adulthood (a Class I recommendation), noting that lifestyle changes minimally affect Lp(a) so repeat testing is generally not needed. confirmedas of 2026-10-11

    9. [9]

      In an editorial comment, the guideline's chair and vice-chair wrote that VESALIUS-CV results should lead future updates to adopt a single care pathway for all patients with ASCVD with an LDL goal below 55 mg/dL. confirmedas of 2026-10-11

    10. [10]

      Merck states it is not yet known whether Lipfendra reduces cardiovascular illness and death; its CORALreef Outcomes trial has enrolled over 14,500 participants, with estimated primary completion in November 2029. confirmedas of 2026-10-11

    11. [11]

      NewAmsterdam said in May 2026 that it would run an interim analysis of the PREVAIL cardiovascular outcomes trial (over 9,500 patients) in the fourth quarter of 2026, expects to report the result in the first quarter of 2027, and anticipates completion by the end of 2027 if the trial does not stop early for efficacy. confirmedas of 2026-10-11

    12. [12]

      On 24 June 2026 the FDA approved Ionis's olezarsen (Tryngolza), a once-monthly self-injected drug, as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (triglycerides of 500 mg/dL or more). confirmedas of 2026-10-11

    13. [13]

      Two large inclisiran outcome trials were active but not recruiting as of October 2026, ORION-4 (16,124 participants, estimated primary completion October 2026) and VICTORION-2P (17,004 participants, estimated primary completion May 2027). confirmedas of 2026-10-11

    14. [14]

      Two other Lp(a)-lowering outcome trials were active but not recruiting as of October 2026, Amgen's OCEAN(a)-Outcomes trial of olpasiran (7,297 participants, estimated primary completion March 2028) and Lilly's lepodisiran trial ACCLAIM-Lp(a) (estimated 17,300 participants, estimated primary completion March 2029). confirmedas of 2026-10-11

    15. [15]

      At the European Society of Cardiology Congress on 28 August 2026, CRISPR Therapeutics reported one-year Phase 1a follow-up for CTX310, with mean reductions from baseline at the highest dose of 79% for ANGPTL3, 48% for triglycerides and 53% for LDL cholesterol, and said no additional treatment-related adverse events had occurred since the previous update; the data were published in NEJM the same day. confirmedas of 2026-08-28

    16. [16]

      On 8 October 2026 CRISPR Therapeutics said Phase 1b data for CTX310 in severe hypertriglyceridemia would be presented in a late-breaking oral session at the American Heart Association Scientific Sessions on 9 November 2026. confirmedas of 2026-10-08

    17. [17]

      In a 6-month randomised trial of 76 women with polycystic ovary syndrome published in 2026, 6-hour time-restricted eating reduced body weight by 4.32% relative to controls, similar to daily calorie restriction. confirmedas of 2026-10-11

    18. [18]

      The peer-reviewed version, published in August 2025 (19,831 NHANES adults, median follow-up 8.1 years), reported that eating duration under 8 hours was associated with higher cardiovascular mortality than 12 to 14 hours (hazard ratio 2.35) but not with all-cause or cancer mortality, and said residual confounding could not be ruled out. confirmedas of 2026-10-11

    19. [19]

      In VESALIUS-CV (12,257 patients with atherosclerosis or diabetes but no previous heart attack or stroke, median follow-up 4.6 years), evolocumab lowered the risk of a first major cardiovascular event versus placebo (5-year estimate 6.2% vs 8.0%; hazard ratio 0.75), with no evidence of a difference in safety events; results were published in November 2025. confirmedas of 2026-10-11

    20. [20]

      Inclisiran blocks the liver's production of PCSK9; in the ORION-10 and ORION-11 trials (1,561 and 1,617 patients on maximum tolerated statins), injections on day 1, day 90 and every 6 months cut LDL cholesterol by about 50% versus placebo, with more injection-site reactions. confirmedas of 2026-10-11

    21. [21]

      In March 2024 researchers presented a conference abstract analysing about 20,000 US adults from NHANES (2003-2018) which found that people whose eating was limited to less than 8 hours a day had a 91% higher risk of cardiovascular death than those eating across 12 to 16 hours. confirmedas of 2026-10-11

    22. [22]

      The AHA noted the 2024 result was a preliminary abstract; its limitations included self-reported diet, eating windows based on just two days of dietary recall, and factors outside eating duration not included in the analysis, and the senior author said the association does not mean time-restricted eating caused cardiovascular death. confirmedas of 2026-10-11

    23. [23]

      A 2025 BMJ network meta-analysis of 99 randomised trials (6,582 adults) found all intermittent fasting and continuous calorie-restriction diets reduced weight versus unrestricted eating; alternate-day fasting was the only form with a small benefit over continuous restriction (-1.29 kg), and longer trials (24 weeks or more) showed benefit only versus unrestricted eating. confirmedas of 2026-10-11

    24. [24]

      In BROADWAY (2,530 patients with ASCVD or heterozygous familial hypercholesterolemia on maximum tolerated lipid-lowering therapy), obicetrapib 10 mg daily, a selective CETP inhibitor, lowered LDL cholesterol by 32.6 percentage points more than placebo at day 84, with similar adverse-event rates. confirmedas of 2026-10-11

    25. [25]

      In the CORALreef Lipids trial (2,909 adults with or at risk of atherosclerotic cardiovascular disease), oral enlicitide 20 mg daily lowered LDL cholesterol by 55.8 percentage points more than placebo at week 24, also lowered non-HDL cholesterol, apolipoprotein B and Lp(a), and adverse events did not appear to differ from placebo. confirmedas of 2026-10-11

    26. [26]

      The Cochrane authors said the included trials focused on effects up to 12 months, that longer follow-up is needed, and that clinicians and patients may need to weigh willingness, practicality and sustainability when considering intermittent fasting. confirmedas of 2026-10-11

    27. [27]

      Merck reported that Lipfendra reduced LDL cholesterol by 56% versus placebo at week 24 in CORALreef Lipids and by 59% in CORALreef HeFH; in CORALreef HeFH, diarrhoea (7% vs 2%) and dizziness (9% vs 4%) were more common than with placebo. confirmedas of 2026-10-11

    28. [28]

      On 24 July 2026 NewAmsterdam Pharma and its European partner Menarini announced that the EMA's CHMP had adopted a positive opinion recommending marketing authorisation for obicetrapib as Ubeslo (monotherapy) and Evlarco (with ezetimibe) for primary hypercholesterolaemia and mixed dyslipidaemia. confirmedas of 2026-10-11

    29. [29]

      On 29 September 2026 NewAmsterdam announced dosing of the first patient in SPINOZA, a Phase 2b trial of obicetrapib in people with preclinical Alzheimer's disease. confirmedas of 2026-10-11

    Revision history (1)
    1. Page created, with timeline through 11 October 2026.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Nov 10, 2026.

    Cite this page

    "Cholesterol and fasting research tracker 2026." ContentLora, updated Oct 11, 2026. https://contentlora.com/events/cholesterol-and-fasting-tracker

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

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