A study to test the safety and efficacy of the study drug in patients with low blood sugar caused by hormones made by their tumor

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rezolute Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

10 Mar 2026 → ongoing

Decision date (initial)

2025-07-21

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2024-515447-36-00

ClinicalTrials.gov

NCT06881992

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Efficacy, Pharmacokinetic, Therapy

To evaluate the glycemic efficacy of ersodetug as measured by the number of participants able to achieve a clinically meaningful reduction in continuous glucose requirements compared to baseline.

Secondary objectives 1

1. To evaluate the glycemic efficacy of ersodetug as measured by the overall continuous glucose requirements.

Conditions and MedDRA coding

Tumor-associated hyperinsulinism

Study design 4 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI which must include an oncologist to ensure the participant is appropriate for this clinical trial.
2. Male or female participants of ≥18 years of age who provide written informed consent as per regulations.
3. Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessments who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
4. Currently requiring IV glucose infusion and/or parenteral nutrition for a specified number of days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).
5. Female participants of childbearing potential must not be pregnant or breast feeding, and willing to use effective contraceptive measures to prevent pregnancy for the duration of the study AND including for up to 5 months after receiving the last dose of study drug.
6. Male participants with female partner of childbearing potential must be willing to use effective contraceptive measures to prevent pregnancy for the duration of the study AND including for up to 5 months after receiving the last dose of study drug.

Exclusion criteria 6

1. Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
2. Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed.
3. Any out-of-range laboratory value at screening (other than blood glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.
4. Known allergy or sensitivity to ersodetug or any component of the drug.
5. Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor’s Medical Monitor would pose an unacceptable risk to the participant in the study.
6. Estimated life expectancy (additional lifespan) due to underlying disease (tumor) as specified in the protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Proportion of participants with clinically meaningful reduction in glucose infusion rate from baseline.
2. OLE: Long-term glycemic efficacy (by SMBG) of ersodetug will be assessed similar to secondary endpoints of the Pivotal Treatment Period (PTP) including SOC antihypoglycemic therapies, HRQoL
3. OLE: Long-term safety and tolerability based on assessments of TEAEs, SAEs, Adverse Events of Special Interest (AESIs), clinical laboratory measurements, immunogenicity assessments, ECG, hepatic ultrasound, vital signs, and physical examination

Secondary endpoints 3

1. Change from baseline in average daily IV glucose/dextrose infusion rate (GIR)
2. Time to complete weaning off IV glucose administration after initiating ersodetug.
3. Change from baseline in average daily total IV glucose delivery (g).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rezolute Inc.

Sponsor organisation

Rezolute Inc.

Address

275 Shoreline Drive Suite 500

City

Redwood City

Postcode

94065-1413

Country

United States

Scientific contact point

Organisation

Rezolute Inc.

Contact name

Aaron Einhorn

Public contact point

Organisation

Rezolute Inc.

Contact name

Rezolute Public Contact Point

Third parties 9

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications