Obesity / GUB-UCN2 / Type 2 Diabetes · Phase 1/2 Trial

A Three-part First-in-human Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB-UCN2 in Healthy Lean and Obese Participants and Participants With T2D

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry entry for a planned first-in-human Phase 1/2 study of GUB-UCN2, a novel agent for obesity and Type 2 Diabetes. The record describes the study protocol and planned enrollment; no efficacy or safety results are available. The study is still recruiting and has not yet reported outcomes.

What was studied

Phase 1/2, Interventional, Randomized, Sequential, Double masking, Treatment purpose. Obesity, Type 2 Diabetes; age from 18 Years; to 75 Years; accepts healthy volunteers. Intervention: Part 1; Part 2; Part 3. Compared with: Placebo. n = 188. 1 site: Germany.

Key findings

Safety

Primary outcome is safety and tolerability; efficacy endpoints are not stated in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a first-in-human Phase 1/2 trial registration with no results reported; the record describes planned enrollment and safety endpoints only.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of Treatment Emergent Adverse Events (assessed at From baseline up to week 22)

DesignPhase 1/2, Interventional, Randomized, Sequential, Double masking, Treatment purpose

PopulationObesity, Type 2 Diabetes; age from 18 Years; to 75 Years; accepts healthy volunteers

Sample size188

InterventionPart 1; Part 2; Part 3

ComparatorPlacebo

Setting1 site: Germany

Reported figures

Quoted from the source exactly as published.

Planned enrollment188

Primary outcome measureNumber of Treatment Emergent Adverse Events, from baseline up to week 22

Treatment period duration (selected cohorts)up to 16 weeks

PhasePhase 1, Phase 2

Caveats

This is a registry record only; no results are reported and study is still recruiting.
Primary outcome is safety and tolerability; efficacy endpoints are not stated in this record.
Absolute numbers of participants per cohort are not specified.
Follow-up duration beyond week 22 is not reported.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

First-in-human Phase 1/2 design with placebo control is appropriate for safety assessment.

Directness

strong

Primary outcome is safety in relevant populations: healthy, obese, and T2D participants.

Consistency

insufficient

Registry record; no results reported, consistency cannot be assessed.

Risk of bias

moderate

Placebo-controlled design reduces bias; early phase limits outcome scope.

Sample adequacy

limited

Estimated 188 participants across three cohorts; adequate for Phase 1/2 safety but modest power.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07702890). This is a study registration, not published results. Lead sponsor: Gubra A/S. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 188 participants (ESTIMATED). Conditions: Obesity, Type 2 Diabetes. Interventions: DRUG: GUB-UCN2; DRUG: Placebo. Primary outcome measures: Number of Treatment Emergent Adverse Events , From baseline up to week 22. Brief summary: The trial will enroll healthy volunteers and individuals living with obesity, with and without Type 2 Diabetes. The study, with a treatment period of up to 16 weeks in selected cohorts, will investigate GUB-UCN2 as both a standalone therapy and on top of standard of care for obesity

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07702890ObesityGUB-UCN2Type 2 DiabetesGubra