Alpelisib in Diabetes Mellitus, Type 2: NCT07778524 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Recruiting
Recruitment status
15
Planned enrollment
2028-08-31
Primary-completion proxy
Executive view
NCT07778524 evaluates Alpelisib in Diabetes Mellitus, Type 2. The disclosed sponsor is Columbia University, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Correlation coefficient between clamp and ACT/MMTT, assessed over Up to 17 hours after dosing alpelisib.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07778524 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Diabetes Mellitus, Type 2 landscape. Drug & Asset MCP drug_fetch was queried for Alpelisib, while Company & Deal Intelligence MCP organization_fetch was queried for Columbia University.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07778524 | Alpelisib | Phase 1 / Recruiting | Columbia University | United States | Correlation coefficient between clamp and ACT/MMTT Up to 17 hours after dosing alpelisib | 2028-08-31 |
| NCT07778719 | Dapagliflozin Propanediol/Metformin Hydrochloride | Not Applicable / Not yet recruiting | Sponsor not reported | China | ΔIGF-1 12 weeks | 2027-10-10 |
| NCT07779343 | Semaglutide (Novo Nordisk) | Not Applicable / Recruiting | Sponsor not reported | Algeria | Percentage of Participants Achieving ≥5% Weight Loss at Month 18 18 months follow-up | 2028-01-23 |
| NCT07775846 | Finerenone | Phase 4 / Not yet recruiting | Zhongshan Hospital Fudan University | China | Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6 Baseline and Month 6 | 2029-02-28 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07778524 is a Phase 1, recruiting study with 15 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Correlation coefficient between clamp and ACT/MMTT” over “Up to 17 hours after dosing alpelisib.” The retrieved endpoint description is: Determination of utility of Alpelisib Challenge Test as measure of pancreatic beta-cell reserve based on correlation of insulin/C-peptide levels and/or insulin secretion rates during MMTT portion of ACT versus gold-standard hyperglycemic clamp.
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 15 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for Diabetes Mellitus, Type 2. These records do not establish direct evidence for NCT07778524 unless the registration number matches.
A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhib…
Phase 2; n=39; Absolute Change in HbA1c(Least Squares Mean) = 0.16 percentage of glycosylated hemoglobin (95% Confidence Interval, -0.32 to 0.63); Absolute Change in HbA1c(Least Squares Mean) = -1.11 percentage of glycosylated hemoglobin (95% Confidence Interval, -1.6 to -0.62) Source: https://clinicaltrials.gov/ct2/show/results/NCT05232071
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweigh…
Phase 3; n=1613; Percent Change From Baseline in Body Weight(Least Squares Mean) = -2.21 percent change (Standard Error, 0.215); Percent Change From Baseline in Body Weight(Least Squares Mean) = -5.50 percent change (Standard Error, 0.356) Source: https://clinicaltrials.gov/ct2/show/results/NCT05872620
A Phase 2, Parallel-Group, Double-Blind 4-arm Study to Investigate the Effects of Treatment With LY3549492 Tablets Compared With Placebo in an Obese or Overweight Population With…
Phase 2; n=1; Other (Not Including Serious) Adverse Events = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT07030868
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Alpelisib is indexed as Small molecule drug with PI3Kα biology and a global stage of Approved. The asset profile lists Novartis Pharma AG as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Columbia University. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Alpelisib is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07778524
Protocol source: https://clinicaltrials.gov/study/NCT07778524
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 September 2026.
Alpelisib in Diabetes Mellitus, Type 2 is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Correlation coefficient between clamp and ACT/MMTT and 2028-08-31 the leading decision points.
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