Obesity / Overweight / Elecoglipron · Phase 3 Trial

A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus

ClinicalTrials.gov · August 20, 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 Phase 3 trial registration for elecoglipron in Asian participants with obesity or overweight, with or without type 2 diabetes. The study is planned but not yet recruiting, and no results are available. The registry entry describes the planned design and primary outcomes only.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Overweight; age from 18 Years. Intervention: Arm 1 - Dose 1; Arm 2 - Dose 2. Compared with: Arm 3 - Placebo — Placebo Comparator. n = 351. 49 sites across 5 countries.

Key findings

Safety

Long-term safety and durability of weight loss beyond 52 weeks not specified.

Who this may help

No clinical impact can be assessed until results are posted. This registration documents the planned design and outcomes for a future efficacy and safety evaluation of elecoglipron for weight management.

Plain-language summary

This is a Phase 3 trial registration with no results posted; the study is not yet recruiting, so no efficacy or safety data are available to evaluate.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Percent change from baseline to Week 52 in body weight (assessed at Week 52); Participants achieving at least 5% body weight loss at Week 52 (assessed at Week 52)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Overweight; age from 18 Years

Sample size351

InterventionArm 1 - Dose 1; Arm 2 - Dose 2

ComparatorArm 3 - Placebo — Placebo Comparator

Setting49 sites across 5 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment351

PhasePhase 3

Primary outcome 1Percent change from baseline to Week 52 in body weight

Primary outcome 2Participants achieving at least 5% body weight loss at Week 52

Study duration52 weeks

Clinical bottom line

Caveats

No results are reported in this registry record; study is not yet recruiting.
Geographic focus is Asian participants; generalizability to other populations unknown.
Comparator is placebo adjunct to diet and exercise; relative efficacy versus active comparators not addressed.
Long-term safety and durability of weight loss beyond 52 weeks not specified.

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

strong

Phase 3 randomized controlled trial with placebo comparator planned.

Directness

strong

Primary outcomes are clinically relevant weight loss endpoints at 52 weeks.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Study design appears controlled but conduct details insufficient to assess bias risk.

Sample adequacy

moderate

Planned enrollment 351 participants; adequacy for stated endpoints not specified.

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 (NCT07775404). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 351 participants (ESTIMATED). Conditions: Obesity, Overweight. Interventions: DRUG: Elecoglipron; DRUG: Placebo. Primary outcome measures: Percent change from baseline to Week 52 in body weight , Week 52; Participants achieving at least 5% body weight loss at Week 52 , Week 52. Brief summary: The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.

Follow from this

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

NCT07775404ObesityOverweightElecoglipronAstraZeneca