A Trial of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight

What Was Tested

The trial (phase 1) is built around Ecnoglutide.

It had three arms (groups): Arm 1, SAD (experimental), Arm 2, MAD (experimental) and Arm 3, MAD (experimental).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 332 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female assigned at birth, inclusive of all gender identities. Have a BMI of:. ≥25 kg/m\^2 and ≤35.0 kg/m\^2 (Arm 1) OR. ≥27 kg/m\^2 and ≤40.0 kg/m\^2 (Arm 2 and Arm 3). Persons of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.

The full record lists 10 inclusion and 6 exclusion criteria; among the exclusions: have a history of hypocalcemia or ionized serum calcium below the normal range at screening.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Ecnoglutide and who got the comparison, which limits bias.

The Ecnoglutide group and the comparison group ran side by side rather than switching.

As a double-blind Ecnoglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2026-07-06 with completion listed for 2028-03.

It ran at 3 sites in Australia (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)). Number of Participants with Adverse Events of Special Interest (AESIs) (time frame: Screening up to End of Study (Arm 1: Day 29, Arm 2: Week 10, and Arm 3: Week 20)). Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from Baseline (time frame: Screening up to Day 8 (Arm 1) or End of Treatment (Arm 2: Week 7 and Arm 3: Week 17)).

It also tracked 7 secondary outcomes, for example Plasma concentrations of VRB-103 and VRB-101, Maximum Observed Plasma Concentration (Cmax) for VRB-103 and VRB-101, Time to Reach Cmax (Tmax) for VRB-103 and VRB-101, Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUCinf) for VRB-103 and VRB-101, Half-life (t1/2) for VRB-103 and VRB-101 and Trough Concentration (Ctrough) of VRB-103 and VRB-101.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ecnoglutide in 332 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ecnoglutide compound page, all human trials.