HALO Technology

Sponsor(s)

No sponsor indicated

Partnerships

No partner indicated

Type of technology

peptide lipidation technology

Administration route

Subcutaneous, Oral

Development state and regulatory approval

Glucagon-like peptide-1 (GLP-1) analogues (GLP-1)

Phase III

Not provided

Description

The HALO (Half-life Augmented Ligand Oligomer) is a peptide lipidation–based drug delivery technology designed to extend the PK of peptide therapeutics, particularly glucagon-like peptide‑1 (GLP‑1) analogues. This approach involves the covalent conjugation of lipid moieties to peptide backbones, a process commonly referred to as peptide lipidation. The resulting modified peptides exhibit prolonged systemic exposure due to reduced clearance and enhanced stability, enabling extended dosing intervals. In addition, the sustained pharmacokinetic profile minimizes peak-to-trough fluctuations.

Technology highlight

1. Enhances plasma protein binding, particularly to albumin, thereby increasing systemic retention. 2. Reduces renal clearance, contributing to prolonged circulation time. 3. Improves resistance to enzymatic degradation, including proteolytic cleavage. 4. Enables the development of ultra‑long‑acting peptide therapeutics with extended pharmacokinetic and pharmacodynamic profiles. 5. HALO utilizes proprietary oligonucleotide sequence which reduces renal clearance.

Technology main components

1) Proprietary Oligonucelotide carrier 2) GLP-1 peptide 2) Proprietary Linker (spacer region) 3) Lipid moiety (fatty acid chain) 4) Stabilizing amino acids

Information on the raw materials sourcing, availability and anticipated price

Not provided

Delivery device(s)

No delivery device

API desired features

Proteins

GLP-1 peptide analogues, NuSH (Nutrient-Stimulated Hormone) analog peptides and other analogues used in the treatment of Overweight and obesity are the targeted molecules for HALO peptide lipidated complex.

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

75-90 wt%

API co-administration

1 single API :

LogP

Not provided

Scale-up prospects

MET-097 (PF-08653944) is planned to be scaled and manufactured by Pfizer, Inc at their Andover, Massachusetts (mammalian cell platform) and Kalamazoo, Michigan (sterile injectables) sites in the United States of America.

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

C6491016

Identifier

NCT07400679

Link

https://clinicaltrials.gov/study/NCT07400679

Phase

Phase I

Status

Not provided

Sponsor

Pfizer

More details

This study is being done to learn how the study medicine affects the body and how safe it is for people who take it. The researchers will look at a number of health tests, including blood tests such as calcitonin, amylase, and lipase, because similar medicines have sometimes caused changes in these tests. This study is seeking participants who are: * Adults who are obese or overweight with weight-related health conditions, and * Meet health and other checks assessed by the study doctor. The study team will give a single dose of the study treatment at the clinic to the participants. At each study visit, blood samples will be collected, vital signs will be checked, and the study team will ask about any reactions or health changes. Vital signs are basic measurements that show how well the

Purpose

A Study to Learn How the Study Medicine Called PF-08653944 is Taken up Into the Blood in Adults With Overweight or Obesity

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2026-02-04

Anticipated Date of Last Follow-up
2026-05-14

Estimated Primary Completion Date
2026-09-18

Estimated Completion Date
2026-09-18

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Key Inclusion Criteria: * Participants 18 years of age or older at Screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. * BMI of 27-45 kg/m2 ; and a total body weight \>50 kg (110 lb). * For Japanese participants only: BMI of 20-45 kg/m2 and a total body weight \>50 kg (110 lb) and must have 4 biological Japanese grandparents who were born in Japan. Key Exclusion Criteria: * Pregnant or breastfeeding women, or those planning pregnancy during the study. * Clinically significant medical conditions including hematologic, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis, gallbladder disease, clinically relevant gastric emptying disorders), cardiovascular, hepatic, psychiatric,

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

54

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

C6491009

Identifier

NCT07519135

Link

https://clinicaltrials.gov/study/NCT07519135

Phase

Phase I

Status

Recruiting

Sponsor

Pfizer

More details

This study is being done to learn more about an investigational medicine called PF-08653944. The goal is to understand how the body handles the medicine and to check its safety after a single dose. The study includes adults with normal liver function and adults who have mild, moderate, or severe liver problems. By comparing these groups, researchers want to understand whether liver function changes how the medicine behaves in the body. People who join the study will receive one injection of the study medicine. They will stay at the study clinic for a short time and return for follow-up visits so doctors can do blood tests, physical exams, and safety checks. This study is not expected to provide direct medical benefit to participants. The information collected will help researchers devel

Purpose

A Study to Learn About the Medicine Called PF-08653944 in People With and Without Reduced Liver Function

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2026-04-15

Anticipated Date of Last Follow-up
2026-04-20

Estimated Primary Completion Date
2027-07-09

Estimated Completion Date
2027-07-09

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Adults 18 to 75 years of age, male or female. * BMI ≥21 kg/m² and body weight \>50 kg at screening. * Group 1 (without hepatic impairment): * No known or suspected hepatic impairment. * Normal liver function tests (ALT, AST, bilirubin, albumin, PT within normal limits, with protocol-specified exceptions such as Gilbert's syndrome). * Groups 2-4 (with hepatic impairment): * Stable hepatic impairment classified as Child-Pugh Class A (mild), B (moderate), or C (severe). * No clinically significant worsening of hepatic status within 28 days prior to screening. * Women of childbearing potential must not be pregnant or breastfeeding and must agree to use highly effective contraception. Exclusion Criteria: * Clinically significant medical or psychiatric conditio

Health status

Study type

Interventional (clinical trial)

Enrollment

26

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

C6491013

Identifier

NCT07595549

Link

https://clinicaltrials.gov/study/NCT07595549

Phase

Phase III

Status

Not yet recruiting

Sponsor

Pfizer

More details

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes. About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe. People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2

Purpose

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

Interventions

Intervention 1

Intervention 2

Countries

Not provided

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-06-30

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
2026-05-26

Estimated Primary Completion Date
2028-05-04

Estimated Completion Date
2028-06-21

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Aged ≥18 years. * BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to \<30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D. Exclusion Criteria: * Have a self-reported body weight change greater than 5% within 90 days prior to Screening. * Diagnosis of type 1 diabetes or any other form of diabetes other than T2D. * History of acute or chronic pancreatitis. * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

954

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

SOLIS-1

Identifier

NCT07575932

Link

https://clinicaltrials.gov/study/NCT07575932

Phase

Phase II

Status

Recruiting

Sponsor

Pfizer

More details

This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).

Purpose

A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)

Interventions

Intervention 1

Intervention 2

Intervention 3

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2026-05-11

Anticipated Date of Last Follow-up
2026-06-09

Estimated Primary Completion Date
2027-08-04

Estimated Completion Date
2028-01-05

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: Eligible participants for this study include: * adults aged 18 years or older with * obesity (BMI of 30.0 kg/m2 to 50.0 kg/m2) or with * overweight (BMI of 27.0 kg/m2 to \<30.0 kg/m2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit. Exclusion Criteria: Participants who are not eligible include those with diabetes mellitus, a body weight change of \>5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.

Health status

Study type

Interventional (clinical trial)

Enrollment

872

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

C6491008

Identifier

NCT07400653

Link

https://clinicaltrials.gov/study/NCT07400653

Phase

Phase III

Status

Recruiting

Sponsor

Pfizer

More details

The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood. The study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week. About 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will hel

Purpose

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2026-02-24

Anticipated Date of Last Follow-up
2026-05-14

Estimated Primary Completion Date
2027-10-12

Estimated Completion Date
2028-05-16

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * Provision of signed and dated informed consent form (ICF) * Male or female adults, aged ≥18 years * Have a BMI at Screening of ≥27.0 kg/m2 * Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria * Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with: --Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin * Participants must be motivated and willing to: * Self-inject study medication (or be aided by caregiver if needed), * Perform fin

Health status

Study type

Interventional (clinical trial)

Enrollment

999

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

C6491010

Identifier

NCT07508241

Link

https://clinicaltrials.gov/study/NCT07508241

Phase

Phase I

Status

Recruiting

Sponsor

Pfizer

More details

This study looks at how a study medicine called PF-08653944 affects how quickly the stomach empties food after eating. It is being done in adults who are overweight or have obesity. Participants will receive the study medicine for a short period, and doctors will measure how the medicine moves through the stomach and monitor safety. The goal is to better understand how this medicine works in the body and to check for any side effects. The information from this study may help researchers plan future studies of this medicine.

Purpose

A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2026-03-31

Anticipated Date of Last Follow-up
2026-04-20

Estimated Primary Completion Date
2027-01-27

Estimated Completion Date
2027-01-27

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: * Adults ≥18 years at screening, male or female, generally healthy as determined by medical history, physical examination, laboratory tests, and ECG. * Body mass index (BMI) 27-45 kg/m² and body weight \>50 kg (110 lb). * Participants with overweight or obesity Exclusion Criteria: * History or presence of clinically significant medical conditions, including but not limited to: --Cardiovascular, hepatic, renal, pulmonary, endocrine, hematologic, neurologic, gastrointestinal (including pancreatitis or gallbladder disease), or significant psychiatric disorders. * Any form of diabetes, HbA1c ≥6.5%, or fasting plasma glucose ≥126 mg/dL. * Prior exposure to a GLP-1 receptor agonist within 90 days before first dose, or prior participation in a study with PF-08653944.

Health status

Study type

Interventional (clinical trial)

Enrollment

20

Allocation

Not provided

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

VESPER-4

Identifier

NCT07311850

Link

https://clinicaltrials.gov/study/NCT07311850

Phase

Phase III

Status

Recruiting

Sponsor

Pfizer

More details

This study investigates the efficacy and safety of once weekly injectable MET097 in adult participants with obesity or overweight with weight-related comorbidities excluding T2D. This trial will last for a duration of 84 weeks. The primary endpoint will be assessed after 64 weeks of treatment with the secondary at 84 weeks.

Purpose

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

Interventions

Intervention 1

Intervention 2

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2025-12-19

Anticipated Date of Last Follow-up
2026-06-10

Estimated Primary Completion Date
2027-09-21

Estimated Completion Date
2028-04-25

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults
• Older Adults

Genders

• All

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion Criteria: * BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to \<30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) Exclusion Criteria: * Have any form of diabetes * Have a self-reported body weight change \> 5 kg (11 pounds) within 3 months prior to Screening * Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) * History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

Health status

Study type

Interventional (clinical trial)

Enrollment

3501

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Double-blind masking

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Treatment

Key resources

Proprietary excipients used

No proprietary excipient used

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

No novel excipient or existing excipient used

Residual solvents used

No residual solvent used

Other features of the technology

Not provided

Release properties

Based on preclinical studies, pharmacokinetic analysis revealed that MET-097 has a mean time to peak concentration of approximately 18 days, with predictable, dose-proportional plasma levels and minimal variability. The accumulation ratio after five weekly doses was approximately three, and a two-fold dose increase resulted in a predictable rise in drug exposure.

Injectability

HALO™ technology–based therapeutics are administered via subcutaneous injection using a 23‑ to 25‑gauge needle, consistent with standard clinical practice for injectable peptide therapeutics.

Safety

No AE-related discontinuations occurred. Common GI AEs (nausea/vomiting) were mostly mild and within the first few weeks of dosing. By day 36 post-treatment, MET097 caused dose-dependent clinically meaningful weight loss, which was maintained through day 85, 8 wks after the last dose.

Stability

Not provided

Storage conditions and cold-chain related features

Not provided

Therapeutic area(s)

Use case(s)

Use of technology

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

<p>CHARLOTTE HINDS, JAMES S. MINNION, GEORGIA ZOUMPOULIDOU; 794-P: MET-097: Preclinical Characterization of a Potent and Ultra-Long-Acting GLP-1 Receptor Agonist. <em>Diabetes</em> 20 June 2025; 74 (Supplement_1): 794–P. <a target="_blank" rel="noopener noreferrer" href="https://doi.org/10.2337/db25-794-P">https://doi.org/10.2337/db25-794-P</a></p>

Introduction and Objective: MET-097 is a potent, fully Gs protein biased glucagon-like peptide-1 receptor agonist (GLP-1RA) currently in phase 2 development for overweight and obesity. Using HALO™ technology, MET-097 was engineered for sustained half-life (t1/2) to potentially allow less frequent dosing. Here we describe the pharmacology of MET-097 in preclinical species in comparison to other NuSH therapies.

Methods: The pharmacokinetics of MET-097 were determined after single and repeat subcutaneous (SC) administration to rats and pigs. The impact of MET-097 on weight was measured in DIO mice over 22 d and compared to equimolar doses of semaglutide, tirzepatide, and other multi-agonists.

Results: The t1/2 of MET-097 was determined to be 24 h in rats and 99 h in pigs, both longer than the t1/2of semaglutide (7.2 h and 46.1 h, literature values). Daily SC administration led to body weight loss that was significantly greater for MET-097 than for semaglutide and tirzepatide (all P values <0.001). At one-third the dose in DIO mice, MET-097 was equally effective as semaglutide and tirzepatide for body weight loss.

Conclusion: Preclinical characterization of MET-097 suggests best-in-class efficacy and an ultra-long t1/2 for MET-097. The long t1/2 of MET-097 may unlock versatile dosing options and scalability advantages due to superior weight loss per mg of peptide.

Additional documents

No documents were uploaded

Useful links

• Robust Phase 2b Efficacy and Favorable Tolerability Support Monthly Dosing for Pfizer’s GLP-1 RA Berobenatide

• Pfizer reports positive results from Phase IIb trial of berobenatide

	Collaborate for development Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided
	Share technical information for match-making assessment Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided
	Work with MPP to expand access in LMICs In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided