Rezolute Announces Completion of Enrollment in Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism

Earlier results showed seven of the first eight participants met the response criterion and completely discontinued intravenous glucose.

Rhea-AI Summary

Rezolute (RZLT) completed enrollment in its Phase 3 upLIFT study of ersodetug for uncontrolled low blood sugar caused by tumor hyperinsulinism. The single-arm, open-label study enrolled 16 participants with insulinoma or non-islet cell tumors. Rezolute expects topline results in mid-December 2026.

The primary endpoint measures participants achieving at least a 50 percent reduction in intravenous glucose infusion rate within the 8-week pivotal treatment phase. Statistical significance requires at least a 56% response rate for 16 participants. Previously reported results showed 7 of the first 8 participants met the endpoint and stopped intravenous glucose completely. The eighth died from cancer progression after choosing hospice care and is counted as a non-responder. No drug-related safety findings have been reported thus far. Rezolute plans to continue compassionate access and potentially advance both tumor and congenital hyperinsulinism indications in 2027 if outcomes are favorable.

7 points · 0 major

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

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Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPhase 3 upLIFT enrollment completed with 16 participants.
• Moderate point7 of the first 8 participants met the primary endpoint responder criterion.
• Minor pointAll seven responders completely discontinued intravenous glucose with ersodetug.
• Minor pointNo drug-related safety findings reported in the study thus far.
• Minor point. Forward-looking: it has not happened yet and may not happen.Rezolute expects topline results in mid-December 2026.

2 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Rezolute plans to continue compassionate access for serious, refractory hypoglycemia due to tumor hyperinsulinism.
• Minor point. Forward-looking: it has not happened yet and may not happen.Rezolute sees potential to advance both indications in 2027, contingent on favorable study outcomes.

Negative

• Moderate pointSingle-arm, open-label design provides no comparison arm or blinded treatment assessment.
• Minor pointOne of the first eight participants died from cancer progression and is counted as a non-responder.

Key Figures

Enrollment: 16 participants Topline results timing: Mid-December 2026 Primary endpoint threshold: At least 50% reduction from baseline in GIR +3 more

Enrollment

16 participants

upLIFT Phase 3 study; enrollment completed

Topline results timing

Mid-December 2026

Expected for the upLIFT study

Primary endpoint threshold

At least 50% reduction from baseline in GIR

Within the 8-week pivotal treatment phase

Statistical significance threshold

Lower 95% CI ≥30%; response rate at least 56% (95% CI 30-80%)

Study criteria for 16 participants

Interim responders

7 of 8 participants

First half of the study met the primary endpoint responder criterion

Interim IV glucose discontinuation

7 participants

Each responder from the first half completely discontinued IV glucose with ersodetug

Previous Clinical trial Reports

1 past event · Latest: Jun 02

Same Type 1 event

1. Jun 02

   Phase 3 interim data

   24h Move

   +10.8%

   upLIFT interim data reported 6 of 8 participants met the responder criterion and discontinued IV glucose.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

open-label, single-arm, glucose infusion rate, confidence interval, +1 more

5 terms

open-label medical

"the open-label Phase 3 study of ersodetug"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

single-arm medical

"a single-arm, open-label, registrational study"

A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

glucose infusion rate medical

"glucose infusion rate (GIR) within the 8-week pivotal treatment phase"

Glucose infusion rate is the speed at which sugar is delivered into the bloodstream through an IV, usually adjusted for body size and expressed as a rate. Think of it as how fast fuel is poured into an engine: too little or too much can change how the body and drugs behave. Investors should care because this rate affects safety, metabolic responses and trial results for treatments or devices that influence blood sugar, which can change regulatory outcomes and market value.

confidence interval technical

"the 95% confidence interval (CI) for the percent responder rate"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

monoclonal antibody medical

"a fully human monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

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Topline results expected mid-December 2026

REDWOOD CITY, Calif., Oct. 14, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (Rezolute or Company), a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI), today announced that the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now fully enrolled and topline data are expected mid-December 2026. The Company plans to continue its expanded access program for purposes of providing ersodetug on a compassionate use basis to individuals living with serious and refractory hypoglycemia due to tumor HI.

The upLIFT study is a single-arm, open-label, registrational study in 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor HI. The study’s primary endpoint is the percent of participants who require intravenous glucose for refractory hypoglycemia that achieve at least a 50 percent reduction from baseline in glucose infusion rate (GIR) within the 8-week pivotal treatment phase. For statistical significance, the lower bound of the 95% confidence interval (CI) for the percent responder rate must be ≥30%, equating to a response rate of at least 56% (95% CI of 30-80%) for 16 participants.

Earlier this year, the Company announced that 7 of the 8 participants enrolled in the first half of the study met the responder criterion for the study’s primary endpoint. Furthermore, each of these participants also achieved complete discontinuation of intravenous glucose with the administration of ersodetug. Ersodetug has been well-tolerated in the study thus far, with no drug-related safety findings reported. The eighth participant in the first half of the study elected to pursue hospice care at home shortly after enrollment, where they died one week later due to cancer progression. The Company considers this participant as a non-responder, for purposes of the primary endpoint.

“Completing enrollment in the upLIFT study marks an important milestone as we advance a potentially transformative treatment option for patients living with tumor hyperinsulinism,” said Dr. Brian Roberts, Chief Medical Officer at Rezolute. “Now that we have a path forward for congenital hyperinsulinism, we look forward to announcing topline data from upLIFT and to the extent the study outcomes are favorable, the potential to advance both indications in 2027. We are deeply grateful to the patients, families, investigators and advocacy groups whose dedication and partnership have enabled us to reach this point.”

About upLIFT

The upLIFT Phase 3 registrational study is a single-arm, open-label, pivotal trial in approximately 16 participants with insulinoma or non-islet cell tumors who have uncontrolled hypoglycemia caused by tumor hyperinsulinism (HI). Eligible participants requiring continuous intravenous (IV) glucose will receive ersodetug 9 mg/kg per week for 8 weeks, as an add-on to standard of care. Following this 8-week pivotal treatment period, all participants may receive ersodetug in long-term extension. The primary endpoint is the proportion of participants able to achieve at least a 50 percent reduction from baseline in IV glucose requirements (glucose infusion rate; GIR). Additional endpoints include the number of participants achieving discontinuation of GIR and time to discontinuation, time to discharge from the hospital, extent of hypoglycemia events and hypoglycemia time in the outpatient setting by self-monitored blood glucose and continuous glucose monitor, respectively, and patient reported quality of life.

About Tumor Hyperinsulinism

Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell tumors (NICTs), both of which lead to hypoglycemia because of over-activation of the insulin receptor. Insulinomas are the most common type of ICT and cause hypoglycemia by stimulating the overproduction of insulin. A variety of different NICTs, including hepatocellular carcinoma and soft tissue malignancies (e.g. sarcomas), can cause hypoglycemia by producing and secreting insulin-like paraneoplastic substances, such as variants of IGF-2, that bind to and activate the insulin receptor. With high morbidity and mortality rates within tumor HI, there remains a significant unmet need for new therapies directed at hypoglycemia treatment. Ersodetug has shown real-world benefit in patients with insulinoma and NICTs.

About Ersodetug 

Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from pancreatic insulin or paraneoplastic IGF-2 secretion and from entero-incretin pathways, it has the potential to be universally effective at treating refractory hypoglycemia due to any form of HI, including congenital HI, tumor HI (insulinoma, non-islet cell tumors) and bariatric/non-bariatric gastrointestinal surgery hypoglycemia. Ersodetug for the treatment of HI is investigational. Statements about safety and efficacy have not been approved by any health authority.

About Rezolute, Inc. 

Rezolute is a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by any form of hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, has been studied in clinical trials and used in real-world cases for the treatment of refractory hypoglycemia due to a variety of causes of HI. For more information, visit www.rezolutebio.com.

Forward-Looking Statements  

This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating hypoglycemia as well as our ability to announce upLIFT topline results this year. Further, even if the upLIFT study results meet the specified endpoint and the study is a success, there can be no assurance that regulatory authorities will ever approve ersodetug for the treatment of tumor or congenital hyperinsulinism. Our ability to predict results or our plans or strategies is inherently uncertain. Actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission’s website at www.sec.gov. You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. 

Contacts: 

Christen Baglaneas
Rezolute, Inc.
1411 Broadway, 16th Floor
New York, NY 10018
cbaglaneas@rezolutebio.com
508-272-6717

Carrie McKim
Rezolute, Inc.
1411 Broadway, 16th Floor
New York, NY 10018
cmckim@rezolutebio.com
336-608-9706

FAQ

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When does Rezolute expect Phase 3 upLIFT results for ersodetug?

Rezolute expects topline results in mid-December 2026. Enrollment is complete in the study of 16 participants with uncontrolled hypoglycemia caused by tumor hyperinsulinism.

What response threshold must Rezolute's upLIFT study meet for statistical significance?

The study requires a response rate of at least 56% for 16 participants, with a 95% confidence interval of 30–80%. The lower bound of that interval must be at least 30%. A responder achieves at least a 50 percent reduction from baseline in intravenous glucose infusion rate within the 8-week pivotal treatment phase.

What treatment do participants receive in Rezolute's upLIFT study?

Eligible participants requiring continuous intravenous glucose receive ersodetug 9 mg/kg per week for 8 weeks, added to standard care. After this pivotal treatment period, all participants may receive ersodetug in a long-term extension.

What other outcomes does Rezolute's upLIFT study measure?

Additional endpoints measure discontinuation of intravenous glucose and the time needed to achieve it, alongside time to hospital discharge. The study also measures outpatient hypoglycemia events using self-monitored blood glucose, time spent with hypoglycemia using continuous glucose monitoring, and patient-reported quality of life.